Trial Outcomes & Findings for EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System (NCT NCT04399928)
NCT ID: NCT04399928
Last Updated: 2025-04-11
Results Overview
Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.
Recruitment status
COMPLETED
Target enrollment
479 participants
Primary outcome timeframe
up to 10 years post-operatively
Results posted on
2025-04-11
Participant Flow
The data from one (1) enrolled hip (1 participant) were entirely removed due to questions regarding the validity of the participant's consent.
Unit of analysis: hips
Participant milestones
| Measure |
R3™ Acetabular System
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Overall Study
STARTED
|
478 501
|
|
Overall Study
COMPLETED
|
350 366
|
|
Overall Study
NOT COMPLETED
|
128 135
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System
Baseline characteristics by cohort
| Measure |
R3™ Acetabular System
n=501 hips
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 9.02 • n=501 hips
|
|
Sex: Female, Male
Female
|
284 hips
n=501 hips
|
|
Sex: Female, Male
Male
|
217 hips
n=501 hips
|
|
Region of Enrollment
Netherlands
|
38 hips
n=501 hips
|
|
Region of Enrollment
Belgium
|
97 hips
n=501 hips
|
|
Region of Enrollment
Finland
|
142 hips
n=501 hips
|
|
Region of Enrollment
Denmark
|
104 hips
n=501 hips
|
|
Region of Enrollment
United Kingdom
|
49 hips
n=501 hips
|
|
Region of Enrollment
Germany
|
38 hips
n=501 hips
|
|
Region of Enrollment
Spain
|
33 hips
n=501 hips
|
|
Body Mass Index (BMI)
|
28.0 kg/m^2
STANDARD_DEVIATION 5.11 • n=501 hips
|
PRIMARY outcome
Timeframe: up to 10 years post-operativelyPopulation: Safety Analysis Population (SAF) included participants enrolled and implanted with the study device with data collected for the time frame indicated.
Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.
Outcome measures
| Measure |
R3™ Acetabular System
n=501 hips
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Implant Survivorship
|
0.89 percentage of hips
Interval 0.865 to 0.923
|
SECONDARY outcome
Timeframe: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 yearsPopulation: Full Analysis Set (FAS) population included participants enrolled and implanted with the study device with data available from at least one post-operative assessment for the time frame indicated.
HOOS is a measurement of function and outcomes of daily living that ranges from 0 to 100 where 0 indicated extreme symptoms (i.e., worse outcome) and 100 indicated no symptoms (i.e., better outcome).
Outcome measures
| Measure |
R3™ Acetabular System
n=449 hips
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
Pre-operative
|
37.8 score on a scale
Standard Deviation 16.16
|
|
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
3 Months
|
83.2 score on a scale
Standard Deviation 12.39
|
|
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
1 Year
|
88.1 score on a scale
Standard Deviation 12.48
|
|
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
3 Years
|
87.9 score on a scale
Standard Deviation 12.22
|
|
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
5 Years
|
88.0 score on a scale
Standard Deviation 13.76
|
|
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
7 Years
|
87.5 score on a scale
Standard Deviation 12.43
|
|
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
10 Years
|
89.3 score on a scale
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 yearsPopulation: Safety Analysis Population (SAF) included participants enrolled and implanted with the study device with data collected for the time frame indicated.
The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit.
Outcome measures
| Measure |
R3™ Acetabular System
n=475 hips
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
Pre-operative
|
51.5 score on a scale
Standard Deviation 14.25
|
|
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
3 Months
|
85.5 score on a scale
Standard Deviation 13.78
|
|
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
1 Year
|
92.2 score on a scale
Standard Deviation 11.67
|
|
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
3 Years
|
92.2 score on a scale
Standard Deviation 10.91
|
|
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
5 Years
|
93.1 score on a scale
Standard Deviation 10.93
|
|
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
7 Years
|
92.3 score on a scale
Standard Deviation 10.90
|
|
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
10 Years
|
92.5 score on a scale
Standard Deviation 10.71
|
SECONDARY outcome
Timeframe: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 yearsPopulation: Safety Analysis Population (SAF) included participants enrolled and implanted with the study device with data collected for the time frame indicated.
UCLA Activity Score is a measure of physical activity levels in participants undergoing total joint arthroplasty. The scale ranges from 1 to 10 with higher scores indicating greater physical function (i.e., a better outcome).
Outcome measures
| Measure |
R3™ Acetabular System
n=488 hips
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
Pre-operative
|
3.4 score on a scale
Standard Deviation 1.35
|
|
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
3 Months
|
5.2 score on a scale
Standard Deviation 1.56
|
|
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
1 Year
|
6.1 score on a scale
Standard Deviation 1.58
|
|
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
3 Years
|
6.1 score on a scale
Standard Deviation 1.66
|
|
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
5 Years
|
6.1 score on a scale
Standard Deviation 1.66
|
|
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
7 Years
|
5.7 score on a scale
Standard Deviation 1.61
|
|
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
10 Years
|
5.6 score on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: 1 years, 3 years, 5 years, 7 years, 10 yearsPopulation: Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated.
Number of participant hips with radiographic findings for atrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years for the following: * Atrophy in any Cup Zones * Atrophy in any Stem Zones
Outcome measures
| Measure |
R3™ Acetabular System
n=431 hips
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Radiographic Findings: Atrophy
1 Year: Atrophy in any Cup Zones · No
|
431 hips
|
|
Radiographic Findings: Atrophy
1 Year: Atrophy in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Atrophy
1 Year: Atrophy in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Atrophy
1 Year: Atrophy in any Stem Zones · No
|
428 hips
|
|
Radiographic Findings: Atrophy
1 Year: Atrophy in any Stem Zones · Yes
|
3 hips
|
|
Radiographic Findings: Atrophy
1 Year: Atrophy in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Atrophy
3 Years: Atrophy in any Cup Zones · No
|
413 hips
|
|
Radiographic Findings: Atrophy
3 Years: Atrophy in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Atrophy
3 Years: Atrophy in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Atrophy
3 Years: Atrophy in any Stem Zones · No
|
411 hips
|
|
Radiographic Findings: Atrophy
3 Years: Atrophy in any Stem Zones · Yes
|
2 hips
|
|
Radiographic Findings: Atrophy
3 Years: Atrophy in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Atrophy
5 Years: Atrophy in any Cup Zones · No
|
357 hips
|
|
Radiographic Findings: Atrophy
5 Years: Atrophy in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Atrophy
5 Years: Atrophy in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Atrophy
5 Years: Atrophy in any Stem Zones · No
|
357 hips
|
|
Radiographic Findings: Atrophy
5 Years: Atrophy in any Stem Zones · Yes
|
0 hips
|
|
Radiographic Findings: Atrophy
5 Years: Atrophy in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Atrophy
7 Years: Atrophy in any Cup Zones · No
|
334 hips
|
|
Radiographic Findings: Atrophy
7 Years: Atrophy in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Atrophy
7 Years: Atrophy in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Atrophy
7 Years: Atrophy in any Stem Zones · No
|
332 hips
|
|
Radiographic Findings: Atrophy
7 Years: Atrophy in any Stem Zones · Yes
|
2 hips
|
|
Radiographic Findings: Atrophy
7 Years: Atrophy in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Atrophy
10 Years: Atrophy in any Cup Zones · No
|
293 hips
|
|
Radiographic Findings: Atrophy
10 Years: Atrophy in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Atrophy
10 Years: Atrophy in any Cup Zones · N/A
|
1 hips
|
|
Radiographic Findings: Atrophy
10 Years: Atrophy in any Stem Zones · No
|
290 hips
|
|
Radiographic Findings: Atrophy
10 Years: Atrophy in any Stem Zones · Yes
|
3 hips
|
|
Radiographic Findings: Atrophy
10 Years: Atrophy in any Stem Zones · N/A
|
1 hips
|
SECONDARY outcome
Timeframe: 1 years, 3 years, 5 years, 7 years, 10 yearsPopulation: Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated.
Number of participant hips with radiographic findings for hypertrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years for the following: * Hypertrophy in any Cup Zones * Hypertrophy in any Stem Zones
Outcome measures
| Measure |
R3™ Acetabular System
n=431 hips
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Radiographic Findings: Hypertrophy
3 Years: Hypertrophy in any Stem Zones · No
|
350 hips
|
|
Radiographic Findings: Hypertrophy
3 Years: Hypertrophy in any Stem Zones · Yes
|
63 hips
|
|
Radiographic Findings: Hypertrophy
3 Years: Hypertrophy in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Hypertrophy
5 Years: Hypertrophy in any Cup Zones · No
|
357 hips
|
|
Radiographic Findings: Hypertrophy
1 Year: Hypertrophy in any Cup Zones · No
|
427 hips
|
|
Radiographic Findings: Hypertrophy
1 Year: Hypertrophy in any Cup Zones · Yes
|
4 hips
|
|
Radiographic Findings: Hypertrophy
1 Year: Hypertrophy in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Hypertrophy
1 Year: Hypertrophy in any Stem Zones · No
|
399 hips
|
|
Radiographic Findings: Hypertrophy
1 Year: Hypertrophy in any Stem Zones · Yes
|
32 hips
|
|
Radiographic Findings: Hypertrophy
1 Year: Hypertrophy in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Hypertrophy
3 Years: Hypertrophy in any Cup Zones · No
|
412 hips
|
|
Radiographic Findings: Hypertrophy
3 Years: Hypertrophy in any Cup Zones · Yes
|
1 hips
|
|
Radiographic Findings: Hypertrophy
3 Years: Hypertrophy in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Hypertrophy
5 Years: Hypertrophy in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Hypertrophy
5 Years: Hypertrophy in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Hypertrophy
5 Years: Hypertrophy in any Stem Zones · No
|
347 hips
|
|
Radiographic Findings: Hypertrophy
5 Years: Hypertrophy in any Stem Zones · Yes
|
10 hips
|
|
Radiographic Findings: Hypertrophy
5 Years: Hypertrophy in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Hypertrophy
7 Years: Hypertrophy in any Cup Zones · No
|
334 hips
|
|
Radiographic Findings: Hypertrophy
7 Years: Hypertrophy in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Hypertrophy
7 Years: Hypertrophy in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Hypertrophy
7 Years: Hypertrophy in any Stem Zones · No
|
325 hips
|
|
Radiographic Findings: Hypertrophy
7 Years: Hypertrophy in any Stem Zones · Yes
|
9 hips
|
|
Radiographic Findings: Hypertrophy
7 Years: Hypertrophy in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Hypertrophy
10 Years: Hypertrophy in any Cup Zones · No
|
293 hips
|
|
Radiographic Findings: Hypertrophy
10 Years: Hypertrophy in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Hypertrophy
10 Years: Hypertrophy in any Cup Zones · N/A
|
1 hips
|
|
Radiographic Findings: Hypertrophy
10 Years: Hypertrophy in any Stem Zones · No
|
281 hips
|
|
Radiographic Findings: Hypertrophy
10 Years: Hypertrophy in any Stem Zones · Yes
|
11 hips
|
|
Radiographic Findings: Hypertrophy
10 Years: Hypertrophy in any Stem Zones · N/A
|
2 hips
|
SECONDARY outcome
Timeframe: 1 years, 3 years, 5 years, 7 years, 10 yearsPopulation: Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated.
Number of participant hips with radiographic findings for osteolysis greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years as the following: * Osteolysis \> 2mm in any Cup Zones * Osteolysis \> 2mm in any Stem Zones
Outcome measures
| Measure |
R3™ Acetabular System
n=431 hips
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Radiographic Findings: Osteolysis
1 Year: Osteolysis > 2mm in any Cup Zones · No
|
403 hips
|
|
Radiographic Findings: Osteolysis
1 Year: Osteolysis > 2mm in any Cup Zones · Yes
|
4 hips
|
|
Radiographic Findings: Osteolysis
1 Year: Osteolysis > 2mm in any Cup Zones · N/A
|
24 hips
|
|
Radiographic Findings: Osteolysis
1 Year: Osteolysis > 2mm in any Stem Zones · No
|
401 hips
|
|
Radiographic Findings: Osteolysis
1 Year: Osteolysis > 2mm in any Stem Zones · Yes
|
5 hips
|
|
Radiographic Findings: Osteolysis
1 Year: Osteolysis > 2mm in any Stem Zones · N/A
|
25 hips
|
|
Radiographic Findings: Osteolysis
3 Years: Osteolysis > 2mm in any Cup Zones · No
|
383 hips
|
|
Radiographic Findings: Osteolysis
3 Years: Osteolysis > 2mm in any Cup Zones · Yes
|
6 hips
|
|
Radiographic Findings: Osteolysis
3 Years: Osteolysis > 2mm in any Cup Zones · N/A
|
24 hips
|
|
Radiographic Findings: Osteolysis
3 Years: Osteolysis > 2mm in any Stem Zones · No
|
380 hips
|
|
Radiographic Findings: Osteolysis
3 Years: Osteolysis > 2mm in any Stem Zones · Yes
|
7 hips
|
|
Radiographic Findings: Osteolysis
3 Years: Osteolysis > 2mm in any Stem Zones · N/A
|
26 hips
|
|
Radiographic Findings: Osteolysis
5 Years: Osteolysis > 2mm in any Cup Zones · No
|
326 hips
|
|
Radiographic Findings: Osteolysis
5 Years: Osteolysis > 2mm in any Cup Zones · Yes
|
6 hips
|
|
Radiographic Findings: Osteolysis
5 Years: Osteolysis > 2mm in any Cup Zones · N/A
|
25 hips
|
|
Radiographic Findings: Osteolysis
5 Years: Osteolysis > 2mm in any Stem Zones · No
|
326 hips
|
|
Radiographic Findings: Osteolysis
5 Years: Osteolysis > 2mm in any Stem Zones · Yes
|
4 hips
|
|
Radiographic Findings: Osteolysis
5 Years: Osteolysis > 2mm in any Stem Zones · N/A
|
27 hips
|
|
Radiographic Findings: Osteolysis
7 Years: Osteolysis > 2mm in any Cup Zones · No
|
322 hips
|
|
Radiographic Findings: Osteolysis
7 Years: Osteolysis > 2mm in any Cup Zones · Yes
|
2 hips
|
|
Radiographic Findings: Osteolysis
7 Years: Osteolysis > 2mm in any Cup Zones · N/A
|
10 hips
|
|
Radiographic Findings: Osteolysis
7 Years: Osteolysis > 2mm in any Stem Zones · No
|
317 hips
|
|
Radiographic Findings: Osteolysis
7 Years: Osteolysis > 2mm in any Stem Zones · Yes
|
7 hips
|
|
Radiographic Findings: Osteolysis
7 Years: Osteolysis > 2mm in any Stem Zones · N/A
|
10 hips
|
|
Radiographic Findings: Osteolysis
10 Years: Osteolysis > 2mm in any Cup Zones · No
|
281 hips
|
|
Radiographic Findings: Osteolysis
10 Years: Osteolysis > 2mm in any Cup Zones · Yes
|
1 hips
|
|
Radiographic Findings: Osteolysis
10 Years: Osteolysis > 2mm in any Cup Zones · N/A
|
12 hips
|
|
Radiographic Findings: Osteolysis
10 Years: Osteolysis > 2mm in any Stem Zones · No
|
273 hips
|
|
Radiographic Findings: Osteolysis
10 Years: Osteolysis > 2mm in any Stem Zones · Yes
|
9 hips
|
|
Radiographic Findings: Osteolysis
10 Years: Osteolysis > 2mm in any Stem Zones · N/A
|
12 hips
|
SECONDARY outcome
Timeframe: 1 years, 3 years, 5 years, 7 years, 10 yearsPopulation: Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated.
Number of participant hips with radiographic findings for radiolucent lines (RLL) greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years as the following: * RLL \> 2mm in any Cup Zones * RLL \> 2mm in any Stem Zones
Outcome measures
| Measure |
R3™ Acetabular System
n=431 hips
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Radiographic Findings: Radiolucent Lines (RLL)
1 Year: RLL > 2mm in any Cup Zones · No
|
431 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
1 Year: RLL > 2mm in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
1 Year: RLL > 2mm in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
1 Year: RLL > 2mm in any Stem Zones · No
|
430 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
1 Year: RLL > 2mm in any Stem Zones · Yes
|
1 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
1 Year: RLL > 2mm in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
3 Years: RLL > 2mm in any Cup Zones · No
|
413 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
3 Years: RLL > 2mm in any Cup Zones · Yes
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
3 Years: RLL > 2mm in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
3 Years: RLL > 2mm in any Stem Zones · No
|
413 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
3 Years: RLL > 2mm in any Stem Zones · Yes
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
3 Years: RLL > 2mm in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
5 Years: RLL > 2mm in any Cup Zones · No
|
356 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
5 Years: RLL > 2mm in any Cup Zones · Yes
|
1 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
5 Years: RLL > 2mm in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
5 Years: RLL > 2mm in any Stem Zones · No
|
357 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
5 Years: RLL > 2mm in any Stem Zones · Yes
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
5 Years: RLL > 2mm in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
7 Years: RLL > 2mm in any Cup Zones · No
|
333 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
7 Years: RLL > 2mm in any Cup Zones · Yes
|
1 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
7 Years: RLL > 2mm in any Cup Zones · N/A
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
7 Years: RLL > 2mm in any Stem Zones · No
|
334 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
7 Years: RLL > 2mm in any Stem Zones · Yes
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
7 Years: RLL > 2mm in any Stem Zones · N/A
|
0 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
10 Years: RLL > 2mm in any Cup Zones · No
|
292 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
10 Years: RLL > 2mm in any Cup Zones · Yes
|
1 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
10 Years: RLL > 2mm in any Cup Zones · N/A
|
1 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
10 Years: RLL > 2mm in any Stem Zones · No
|
292 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
10 Years: RLL > 2mm in any Stem Zones · Yes
|
1 hips
|
|
Radiographic Findings: Radiolucent Lines (RLL)
10 Years: RLL > 2mm in any Stem Zones · N/A
|
1 hips
|
Adverse Events
R3™ Acetabular System
Serious events: 371 serious events
Other events: 329 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
R3™ Acetabular System
n=478 participants at risk
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Injury, poisoning and procedural complications
Fissure
|
0.84%
4/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Elevated Metal Ions
|
0.42%
2/478 • Number of events 3 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Delayed Wound Healing
|
0.84%
4/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Disturbance of skin sensation
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Bursitis
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Cyst
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Death from unknown causes
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Deep Infection <6 weeks
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Deep Infection >6 weeks
|
0.63%
3/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Deep Vein Thrombosis
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Groin pain, study hip side
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Hematoma, Hemarthrosis
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Inflammation
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Injury, poisoning, or consequence of external causes
|
2.9%
14/478 • Number of events 14 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Leg Length Change
|
1.5%
7/478 • Number of events 7 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Leg Pain
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Limp, study hip side
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Myalgia, muscle pain
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Operative side pain originating from other than study hip
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Pain in study hip
|
2.1%
10/478 • Number of events 12 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Perioperative Fever
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Perioperative Pulmonary Embolism
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Post-op swelling of study leg
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Pseudotumor
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Reaction to metal debris/ metal allergy
|
4.6%
22/478 • Number of events 22 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Tendonitis
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Trochanteritis
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Eye disorders
Eye/Adnexa
|
10.5%
50/478 • Number of events 65 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Death from unknown causes
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
9.0%
43/478 • Number of events 61 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Symptoms not otherwise defined
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Cardiac disorders
Circulatory
|
11.1%
53/478 • Number of events 83 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Cardiac disorders
Death from unknown causes
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Nervous system disorders
Nervous
|
10.5%
50/478 • Number of events 61 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Nervous system disorders
Pain, unknown etiology
|
0.84%
4/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Nervous system disorders
Symptoms not otherwise defined
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
General disorders
Death from unknown causes
|
0.84%
4/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
General disorders
Pain, unknown etiology
|
0.63%
3/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Blood and lymphatic system disorders
Lymphatic
|
0.63%
3/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Skin and subcutaneous tissue disorders
Skin/Subcutaneous Tissue
|
3.3%
16/478 • Number of events 17 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Ear and labyrinth disorders
Ear/Mastoid Process
|
0.84%
4/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Psychiatric disorders
Mental/behavioral
|
2.3%
11/478 • Number of events 12 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Hepatobiliary disorders
Digestive/Gastrointestinal
|
0.63%
3/478 • Number of events 3 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Bone Fracture- Femur
|
3.1%
15/478 • Number of events 16 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Digestive/Gastrointestinal
|
1.7%
8/478 • Number of events 8 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
2.1%
10/478 • Number of events 14 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Heterotopic Ossification: Grade I
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Muscular/Connective Tissue
|
5.9%
28/478 • Number of events 32 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Pain, unknown etiology
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Skeletal
|
39.1%
187/478 • Number of events 298 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Superficial Infection Only
|
0.84%
4/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Symptoms not otherwise defined
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, known origin
|
11.9%
57/478 • Number of events 71 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, unknown type
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death from unknown causes
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Renal and urinary disorders
Urinary
|
7.9%
38/478 • Number of events 47 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Reproductive system and breast disorders
Reproductive System
|
3.6%
17/478 • Number of events 18 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Vascular disorders
Circulatory
|
9.6%
46/478 • Number of events 62 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Vascular disorders
Death from unknown causes
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Vascular disorders
Hematologic/Immune System
|
2.5%
12/478 • Number of events 12 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Metabolism and nutrition disorders
Endocrine/Nutritional/Metabolic
|
4.4%
21/478 • Number of events 25 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Infections and infestations
Infection
|
4.4%
21/478 • Number of events 23 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Gastrointestinal disorders
Digestive/Gastrointestinal
|
10.7%
51/478 • Number of events 71 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Product Issues
Acetabular
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Product Issues
Femoral
|
1.0%
5/478 • Number of events 5 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Product Issues
Femoral Component
|
1.3%
6/478 • Number of events 6 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Product Issues
Implant Failure
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Product Issues
Other
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Endocrine disorders
Endocrine/Nutritional/Metabolic
|
2.7%
13/478 • Number of events 13 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
Other adverse events
| Measure |
R3™ Acetabular System
n=478 participants at risk
Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem)
|
|---|---|
|
Injury, poisoning and procedural complications
Back pain related to hip
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Bursitis
|
1.3%
6/478 • Number of events 6 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Deep Infection <6 weeks
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Delayed Wound Healing
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Disturbance of skin sensation
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Ectopic Bone Formation
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Elevated Metal Ions
|
4.8%
23/478 • Number of events 30 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Fissure
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Fluid Accumulation
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Groin pain, study hip side
|
1.5%
7/478 • Number of events 7 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Hematoma, Hemarthrosis
|
0.63%
3/478 • Number of events 3 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Hip Discomfort, soreness, or cramping, may be intermittent
|
1.5%
7/478 • Number of events 7 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Hip Squeaking/Clicking/Popping/Snapping or other noise
|
0.63%
3/478 • Number of events 3 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Inflammation
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Injury, poisoning, or consequence of external causes
|
3.6%
17/478 • Number of events 20 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Leg Pain
|
0.84%
4/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Limp, study hip side
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Myalgia, muscle pain
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Operative side pain originating from other than study hip
|
0.21%
1/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Pain at Op site
|
0.84%
4/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Pain in study hip
|
5.2%
25/478 • Number of events 32 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Periaticular Calcification
|
0.63%
3/478 • Number of events 3 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Perioperative Fever
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Post-op swelling of study leg
|
0.84%
4/478 • Number of events 4 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Pseudotumor
|
1.3%
6/478 • Number of events 6 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Psoas Tenopathy
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Reaction to metal debris/ metal allergy
|
1.5%
7/478 • Number of events 7 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Stiffness
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Stress Shielding
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Tenderness in the trochanteric region
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Trendelenberg gait
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Trochanteritis
|
2.1%
10/478 • Number of events 10 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Weakness in study leg
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Eye disorders
Eye/Adnexa
|
2.7%
13/478 • Number of events 14 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
6.7%
32/478 • Number of events 36 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Symptoms not otherwise defined
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Cardiac disorders
Circulatory
|
3.3%
16/478 • Number of events 17 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Nervous system disorders
Nervous
|
7.7%
37/478 • Number of events 42 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Nervous system disorders
Pain, unknown etiology
|
1.7%
8/478 • Number of events 9 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Nervous system disorders
Symptoms not otherwise defined
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
General disorders
Other
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
General disorders
Pain, unknown etiology
|
1.3%
6/478 • Number of events 6 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
General disorders
Symptoms not otherwise defined
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Blood and lymphatic system disorders
Lymphatic
|
1.7%
8/478 • Number of events 8 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Skin and subcutaneous tissue disorders
Other
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Skin and subcutaneous tissue disorders
Skin/Subcutaneous Tissue
|
7.5%
36/478 • Number of events 41 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Ear and labyrinth disorders
Ear/Mastoid Process
|
4.6%
22/478 • Number of events 26 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Ear and labyrinth disorders
Special Sense
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Psychiatric disorders
Mental/behavioral
|
4.6%
22/478 • Number of events 23 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Bone Fracture- Femur
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Cortical Thickening
|
0.21%
1/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Digestive/Gastrointestinal
|
0.63%
3/478 • Number of events 3 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Endocrine/Nutritional/Metabolic
|
1.3%
6/478 • Number of events 6 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Fracture-Subtrochanteric
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Heterotopic Ossification- Generic Reporting
|
0.63%
3/478 • Number of events 3 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Heterotopic Ossification: Grade I
|
2.9%
14/478 • Number of events 14 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Muscular/Connective Tissue
|
9.8%
47/478 • Number of events 60 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Pain, unknown etiology
|
1.7%
8/478 • Number of events 9 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Skeletal
|
36.6%
175/478 • Number of events 328 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Subluxation, no component specified
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Superficial Infection Only
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Musculoskeletal and connective tissue disorders
Symptoms not otherwise defined
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, known origin
|
2.1%
10/478 • Number of events 10 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Renal and urinary disorders
Urinary
|
5.6%
27/478 • Number of events 30 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Reproductive system and breast disorders
Pain, unknown etiology
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Reproductive system and breast disorders
Reproductive System
|
2.3%
11/478 • Number of events 11 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Reproductive system and breast disorders
Urinary
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Vascular disorders
Circulatory
|
5.6%
27/478 • Number of events 32 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Vascular disorders
Hematologic/Immune System
|
3.3%
16/478 • Number of events 17 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Vascular disorders
Symptoms not otherwise defined
|
0.21%
1/478 • Number of events 1 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Metabolism and nutrition disorders
Endocrine/Nutritional/Metabolic
|
3.8%
18/478 • Number of events 24 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Infections and infestations
Infection
|
2.7%
13/478 • Number of events 14 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Gastrointestinal disorders
Digestive/Gastrointestinal
|
8.4%
40/478 • Number of events 48 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Gastrointestinal disorders
Symptoms not otherwise defined
|
0.63%
3/478 • Number of events 3 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Product Issues
Femoral Component
|
0.42%
2/478 • Number of events 2 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
|
Endocrine disorders
Endocrine/Nutritional/Metabolic
|
2.3%
11/478 • Number of events 11 • Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place