Trial Outcomes & Findings for Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee (NCT NCT00854295)
NCT ID: NCT00854295
Last Updated: 2023-02-14
Results Overview
Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
266 participants
Primary outcome timeframe
Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year
Results posted on
2023-02-14
Participant Flow
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeons experienced in primary total knee replacement. Subjects who had one operative knee were in the Unilateral Group and subjects who had two operative knees were in the Bilateral Group. These subjects are considered "Group 2" per the study protocol.
All cases in "Group 1" per the protocol (subjects in the previous IDE study who were eligible to participate in the PAS) have study completed and are not included in these results. A final report for Group 1 was previously approved by FDA on June 29, 2016. Since 2016, only data from Group 2 subjects (PAS Group) was reported to FDA and are applicable to this clinicatrials.gov record.
Participant milestones
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee.
|
LPS Flex Mobile Bilateral Group (Group 2)
Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in both knees.
|
LPS Flex Fixed (Group 1)
Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
|
LPS Flex Mobile (Group 1)
Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
106
|
14
|
77
|
69
|
|
Overall Study
COMPLETED
|
65
|
8
|
54
|
44
|
|
Overall Study
NOT COMPLETED
|
41
|
6
|
23
|
25
|
Reasons for withdrawal
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee.
|
LPS Flex Mobile Bilateral Group (Group 2)
Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in both knees.
|
LPS Flex Fixed (Group 1)
Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
|
LPS Flex Mobile (Group 1)
Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
|
|---|---|---|---|---|
|
Overall Study
Death
|
7
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
6
|
1
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
18
|
5
|
21
|
21
|
|
Overall Study
Physician Decision
|
10
|
0
|
0
|
0
|
Baseline Characteristics
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Baseline characteristics by cohort
| Measure |
LPS Flex Mobile Uniliteral (Group 2)
n=106 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral (Group 2)
n=14 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
LPS Flex Fixed (Group 1)
n=77 Participants
Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
|
LPS Flex Mobile (Group 1)
n=69 Participants
Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.8 Years
n=5 Participants
|
62.4 Years
n=7 Participants
|
61.4 Years
n=5 Participants
|
62.5 Years
n=4 Participants
|
65.4 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
239 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
106 participants
n=5 Participants
|
14 participants
n=7 Participants
|
77 participants
n=5 Participants
|
69 participants
n=4 Participants
|
266 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 yearPopulation: Only subjects with an evaluable endpoint at each time frame interval were used to calculate mean and standard deviations.
Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Outcome measures
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
n=106 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral Group (Group 2)
n=14 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
|---|---|---|
|
Group 2 - Total Knee Society Score (KSS)
1 Year
|
159.2 score on a scale
Standard Deviation 28.1
|
137.2 score on a scale
Standard Deviation 56.9
|
|
Group 2 - Total Knee Society Score (KSS)
Pre-op
|
92.2 score on a scale
Standard Deviation 28.5
|
78.5 score on a scale
Standard Deviation 29
|
|
Group 2 - Total Knee Society Score (KSS)
6 Week
|
118.2 score on a scale
Standard Deviation 33
|
96.7 score on a scale
Standard Deviation 34
|
|
Group 2 - Total Knee Society Score (KSS)
6 Month
|
148 score on a scale
Standard Deviation 29.7
|
130.4 score on a scale
Standard Deviation 51.5
|
|
Group 2 - Total Knee Society Score (KSS)
2 Year
|
159.2 score on a scale
Standard Deviation 32.2
|
149.4 score on a scale
Standard Deviation 34.7
|
|
Group 2 - Total Knee Society Score (KSS)
3 Year
|
161.1 score on a scale
Standard Deviation 27.3
|
147.3 score on a scale
Standard Deviation 45.3
|
|
Group 2 - Total Knee Society Score (KSS)
4 Year
|
160.2 score on a scale
Standard Deviation 29.4
|
121.3 score on a scale
Standard Deviation 56.7
|
|
Group 2 - Total Knee Society Score (KSS)
5 Year
|
160.8 score on a scale
Standard Deviation 28.6
|
167.1 score on a scale
Standard Deviation 29.3
|
PRIMARY outcome
Timeframe: 5 yearPopulation: Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.
Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."
Outcome measures
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
n=106 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral Group (Group 2)
n=14 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
|---|---|---|
|
Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss
|
90 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 5 yearPopulation: Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.
Revision is defined as "No intended, actual, or planned removal of any component of the knee system."
Outcome measures
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
n=106 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral Group (Group 2)
n=14 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
|---|---|---|
|
Group 2 - Number of Subjects With Absence of Implant Revision
|
103 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 5 yearPopulation: Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.
All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.
Outcome measures
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
n=106 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral Group (Group 2)
n=14 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
|---|---|---|
|
Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication
|
105 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 4 year, 5 year, 6 year, 8 year, and 10 yearPopulation: Only subjects with an evaluable endpoint at each time frame interval were used to calculate mean and standard deviations.
Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Outcome measures
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
n=77 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral Group (Group 2)
n=69 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
|---|---|---|
|
Group 1 - Total Knee Society Score (KSS)
10 Year
|
166.6 score on a scale
Standard Deviation 25.5
|
170.8 score on a scale
Standard Deviation 29.3
|
|
Group 1 - Total Knee Society Score (KSS)
4 Year
|
164.6 score on a scale
Standard Deviation 32.9
|
184.4 score on a scale
Standard Deviation 9.7
|
|
Group 1 - Total Knee Society Score (KSS)
5 Year
|
142.4 score on a scale
Standard Deviation 32.2
|
142.6 score on a scale
Standard Deviation 41.3
|
|
Group 1 - Total Knee Society Score (KSS)
6 Year
|
161.9 score on a scale
Standard Deviation 28.1
|
169.3 score on a scale
Standard Deviation 29.8
|
|
Group 1 - Total Knee Society Score (KSS)
8 Year
|
164.8 score on a scale
Standard Deviation 31.0
|
172.0 score on a scale
Standard Deviation 26.9
|
PRIMARY outcome
Timeframe: 10 yearPopulation: Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.
Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."
Outcome measures
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
n=72 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral Group (Group 2)
n=63 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
|---|---|---|
|
Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss
|
65 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: 10 yearPopulation: Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.
Revision is defined as "No intended, actual, or planned removal of any component of the knee system."
Outcome measures
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
n=77 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral Group (Group 2)
n=69 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
|---|---|---|
|
Group 1 - Number of Subjects With Absence of Implant Revision
|
75 Participants
|
68 Participants
|
PRIMARY outcome
Timeframe: 10 yearPopulation: Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.
All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.
Outcome measures
| Measure |
LPS Flex Mobile Unilateral Group (Group 2)
n=77 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral Group (Group 2)
n=69 Participants
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
|---|---|---|
|
Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication
|
75 Participants
|
67 Participants
|
Adverse Events
LPS Flex Mobile Unilateral (Group 2)
Serious events: 17 serious events
Other events: 82 other events
Deaths: 7 deaths
LPS Flex Mobile Bilateral (Group 2)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
LPS Flex Fixed (Group 1)
Serious events: 8 serious events
Other events: 64 other events
Deaths: 1 deaths
LPS Flex Mobile (Group 1)
Serious events: 5 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
LPS Flex Mobile Unilateral (Group 2)
n=106 participants at risk
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral (Group 2)
n=14 participants at risk
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
LPS Flex Fixed (Group 1)
n=77 participants at risk
Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
|
LPS Flex Mobile (Group 1)
n=69 participants at risk
Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device
|
|---|---|---|---|---|
|
Gastrointestinal disorders
COLON CANCER
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
ILIAC CREST FUSION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
LUMBAR FUSION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
CERVICAL FUSION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE JOINT REPLACEMENT SURGERY
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Nervous system disorders
CRAINIOTOMY
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
TOTAL HIP JOINT REPLACEMENT
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
MYELOMA
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
PATIENT TRIPPED AND FELL HYPERFLEXING HER KNEE AND HAD PAIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
DEGENERATIVE JOINT DISEASE OF RIGHT HIP
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
INCREASED SWELLING AND PAIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Infections and infestations
WOUND DRAINAGE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Reproductive system and breast disorders
BREAST CANCER
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
POSTERIOR DISLOCATION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Renal and urinary disorders
BLADDER TUMORS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Blood and lymphatic system disorders
SUPERFICIAL HEMATOMA
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Reproductive system and breast disorders
UTERINE CANCER
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Cardiac disorders
CARDIAC BYPASS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.6%
2/77 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE ARTHRITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE PAIN
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.6%
2/77 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.9%
2/69 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
HIP PAIN
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Cardiac disorders
STROKE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
TIBIAL COMPONENT LOOSENING
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.9%
2/69 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
Other adverse events
| Measure |
LPS Flex Mobile Unilateral (Group 2)
n=106 participants at risk
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
|
LPS Flex Mobile Bilateral (Group 2)
n=14 participants at risk
Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
|
LPS Flex Fixed (Group 1)
n=77 participants at risk
Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
|
LPS Flex Mobile (Group 1)
n=69 participants at risk
Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
ACUTE BLOOD LOSS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
ADHESIVE CAPSULITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Immune system disorders
ALLERGIC REACTION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Nervous system disorders
ALZHEIMERS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
ANEMIA
|
2.8%
3/106 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
ANKLE FRACTURE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
ANKLE PAIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
ANKLE TENDINITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Cardiac disorders
AORTIC ANEURYSM VALVE REPLACEMENT
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA SHOULDER
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
BACK INJURY
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.8%
4/106 • Number of events 4 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
3.9%
3/77 • Number of events 6 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
4.3%
3/69 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN MOLE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
BICEP TEAR
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
BICEP TENDON STRAIN
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Renal and urinary disorders
BLADDER INCONTINENCE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Skin and subcutaneous tissue disorders
BLISTERS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Reproductive system and breast disorders
BREAST CANCER
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITITS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
General disorders
BURNING IN LEGS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BURSITIS
|
3.8%
4/106 • Number of events 4 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.6%
2/77 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
BUTTOCKS BRUISE FROM FALL
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.9%
2/69 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
BUTTOCKS PAIN
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
CALF PAIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
CALF STIFFNESS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Renal and urinary disorders
CARCINOMA
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
CARPAL TUNNEL SYNDROME
|
2.8%
3/106 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.9%
2/69 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
CARPOMETACARPAL ARTHRITIS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Eye disorders
CATARACT SURGERY
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Infections and infestations
CELLULITIS
|
1.9%
2/106 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
28.6%
4/14 • Number of events 5 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Respiratory, thoracic and mediastinal disorders
CHEST PAIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Renal and urinary disorders
CHOLECYSTECTOMY
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
CHONDROMALACIA
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC BRONCHITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Immune system disorders
CLL
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Cardiac disorders
CONGESTIVE HEART FAILURE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Renal and urinary disorders
CONSTIPATION
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Skin and subcutaneous tissue disorders
CONTACT DERMATITIS
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
CREPITATION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
DEGENERATIVE DISC DISEASE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
DEGENERATIVE JOINT DISEASE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
5.2%
4/77 • Number of events 4 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
8.7%
6/69 • Number of events 6 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Infections and infestations
DELAY WOUND HEALING
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Psychiatric disorders
DEPRESSION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Nervous system disorders
DIMINSHED SENSATION
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
11.7%
9/77 • Number of events 9 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
DISC BULGE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
DISLOCATION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
DISTAL RADIUS FRACTURE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
General disorders
DIZZINESS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
DROP FOOT
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Skin and subcutaneous tissue disorders
DRY SKIN ON KNEE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
ELBOW PAIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
ELEVATED BLOOD GLUCOSE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Infections and infestations
ETIOLOGY
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Blood and lymphatic system disorders
FACIAL BLEEDING
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
FAILED TOTAL HIP ARTHROPLASTY
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.6%
2/77 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
FALL
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
FEMUR FRACTURE FROM FALL
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
General disorders
FEVER
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
FLEXION CONTRACTURE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
FLUID IN KNEE
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
FOOT INJURY
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
FOOT PAIN
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.9%
2/69 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
GAIT ANOMOLY
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Skin and subcutaneous tissue disorders
GASTRIC ULCER
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
GASTROCNEMIUS RUPTURE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.6%
2/77 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
HAND ARTHRITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Nervous system disorders
HAND NUMBNESS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
HAND OSTEOARTHRITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
HAND PAIN FROM FALL
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
HAND PARESTHESIAS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
HAND TENDON RELEASE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
HEMATOMA
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
HERNIA
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
HIP FRACTURE FROM FALL
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
HIP OSTEOARTHRITIS
|
3.8%
4/106 • Number of events 4 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
5.2%
4/77 • Number of events 4 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
HIP PAIN
|
7.5%
8/106 • Number of events 9 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.9%
2/69 • Number of events 4 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
HIP TROCHANTERIC BURSITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
3.9%
3/77 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
HYPOGLYCEMIA
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Cardiac disorders
INCREASED TROPONIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Infections and infestations
INFECTION
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
INSTABILITY
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.9%
2/69 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Renal and urinary disorders
KIDNEY CANCER
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE ANKYLOSIS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE BUCKLING
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE CLICKING
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE EFFUSION
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
3.9%
3/77 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE INFLAMMATION
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE OSTEOARTHRITIS
|
11.3%
12/106 • Number of events 12 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
3.9%
3/77 • Number of events 4 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
5.8%
4/69 • Number of events 5 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE PAIN
|
36.8%
39/106 • Number of events 54 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
50.0%
7/14 • Number of events 11 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
19.5%
15/77 • Number of events 18 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
17.4%
12/69 • Number of events 12 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
KNEE PAIN FROM FALL
|
6.6%
7/106 • Number of events 7 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.8%
6/77 • Number of events 6 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
10.1%
7/69 • Number of events 7 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE SCAR TISSUE
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE STIFFNESS
|
13.2%
14/106 • Number of events 15 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE STRESS FRACTURE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.9%
2/69 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE SUBLUXATION
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE SWELLING
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
KNEE TENDONITIS
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
L-4 FRACTURE FROM FALL
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
LAXITY SOFT TISSUE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
LEG EDEMA
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
LEG PAIN
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Eye disorders
LENS BROKE FROM CATARACTS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
LEUKOCYTOSIS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
LOW H AND H IN AM HGL 8.3 H T 24.8
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
LOW HEMOGLOBIN
|
2.8%
3/106 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Respiratory, thoracic and mediastinal disorders
LOW OXYGEN LEVELS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
LUMBAR PAIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Immune system disorders
LUPUS FLARE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Reproductive system and breast disorders
MASTECTOMY
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
MENISCUS TEAR
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.6%
2/77 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
METATORSAL DISPLACEMENT
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Nervous system disorders
NEUROPATHY
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
NUCLEUS PULPOSIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
OSTEOLYSIS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
OSTEOLYTIC CHANGES OF TIBIAL PLATEAU
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
PAIN FROM FALL
|
2.8%
3/106 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
PATELLA CLUNK
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
PATELLA FRACTURE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Nervous system disorders
PERONEAL NERVE PALSY
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Nervous system disorders
PINCHED NERVE IN ARM AND NECK
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Nervous system disorders
PINCHED NERVE SHOULDER
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
PLANTAR FASCITIS
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Renal and urinary disorders
PROSTATE CARCINOMA
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Blood and lymphatic system disorders
PULMONARY EMBOLISM
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
RADIOLUCENCY
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Gastrointestinal disorders
REFLUX
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Renal and urinary disorders
RENAL INSUFFICIENCY
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
RIB FRACTURE FROM FALL
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SURGERY
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF TEAR
|
1.9%
2/106 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SCIATICA
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
3.9%
3/77 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SHOULDER ARTHRITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
SHOULDER INJURY
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
3.8%
4/106 • Number of events 4 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
2.6%
2/77 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
4.3%
3/69 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
SHOULDER STITCHES AFTER FALL
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SI JOINT PAIN
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SIATICA PAIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Respiratory, thoracic and mediastinal disorders
SINUSITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Infections and infestations
SKIN INFECTION ON INCISION
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
SNAKE BITE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SPINAL LSP
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SPINAL STENOSIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
5.2%
4/77 • Number of events 4 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
4.3%
3/69 • Number of events 3 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SPINE ARTHRITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SPINE NERVE ROOT IMPINGEMENTS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
TENDINITIS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
THIGH PAIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Endocrine disorders
THYROID NODULE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
TIBIAL CYSTS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
TORN MENISCUS
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
TOTAL HIP ARTHROPLASTY
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
TOTAL KNEE ARTHROPLASTY
|
4.7%
5/106 • Number of events 5 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
14.3%
2/14 • Number of events 2 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
TOTAL SHOULDER ARTHROPLASTY
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
TRAUMATIC BRAIN INJURY
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
TRIGGER FINGER
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Infections and infestations
TUMOR EXCISION
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Skin and subcutaneous tissue disorders
ULCER
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
VARISCOSE VEIN
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
7.1%
1/14 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
VERTEBRAL FRACTURE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
WEAKNESS IN FOOT
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
WOUND DRAINAGE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
WRIST ARTHRITIS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
WRIST FRACTURE
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.3%
1/77 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
WRIST MASS
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Musculoskeletal and connective tissue disorders
WRIST PAIN
|
0.00%
0/106 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
1.4%
1/69 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
|
Injury, poisoning and procedural complications
YELLOW DRAINAGE
|
0.94%
1/106 • Number of events 1 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/14 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/77 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
0.00%
0/69 • Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place