Trial Outcomes & Findings for POLARSTEM Cementless Hip Stem (NCT NCT02648152)
NCT ID: NCT02648152
Last Updated: 2026-01-21
Results Overview
Overall survivorship of the Cementless Version of the POLARSTEM pre-operatively, 3 months, 12 months, 12 months, 36 months, 60 months, and 120 months by Kaplan-Meier estimate with overall hip survivorship defined as the time between date of treatment and date of revision for any reason.
Recruitment status
COMPLETED
Target enrollment
218 participants
Primary outcome timeframe
Pre-operatively, 3 months, 12 months, 36 months, 60 months, and 120 months
Results posted on
2026-01-21
Participant Flow
Participants were enrolled at three centers in two countries in Europe (2 in Germany and 1 in Switzerland)
Unit of analysis: hips
Participant milestones
| Measure |
Total Hip Arthroplasty
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Overall Study
STARTED
|
218 225
|
|
Overall Study
COMPLETED
|
94 96
|
|
Overall Study
NOT COMPLETED
|
124 129
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
POLARSTEM Cementless Hip Stem
Baseline characteristics by cohort
| Measure |
Total Hip Arthroplasty
n=225 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Age, Continuous
|
64.70 years
STANDARD_DEVIATION 7.70 • n=218 Participants
|
|
Age, Customized
Age Group · <= 60 years
|
62 Participants
n=218 Participants
|
|
Age, Customized
Age Group · > 60 years
|
156 Participants
n=218 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=218 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=218 Participants
|
|
Body Mass Index (BMI)
|
28.30 kg/m^2
STANDARD_DEVIATION 4.72 • n=218 Participants
|
PRIMARY outcome
Timeframe: Pre-operatively, 3 months, 12 months, 36 months, 60 months, and 120 monthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
Overall survivorship of the Cementless Version of the POLARSTEM pre-operatively, 3 months, 12 months, 12 months, 36 months, 60 months, and 120 months by Kaplan-Meier estimate with overall hip survivorship defined as the time between date of treatment and date of revision for any reason.
Outcome measures
| Measure |
Total Hip Arthroplasty
n=225 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM
3 Months
|
99.6 percentage of hips
Interval 96.9 to 99.9
|
|
Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM
Pre-operatively
|
100 percentage of hips
Lower and Upper 95% Confidence Interval limit not estimable for baseline (pre-operative) time point.
|
|
Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM
12 Months
|
99.1 percentage of hips
Interval 96.5 to 99.8
|
|
Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM
36 Months
|
98.7 percentage of hips
Interval 95.9 to 99.6
|
|
Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM
60 Months
|
98.7 percentage of hips
Interval 95.9 to 99.6
|
|
Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM
120 Months
|
98.7 percentage of hips
Interval 95.9 to 99.6
|
SECONDARY outcome
Timeframe: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 monthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
The HHS measured function, range of motion (ROM), and pain sub-scores that are combined to indicate total dysfunction on a numerical scale from 0 to 100, with a higher score indicating less dysfunction (i.e., a better outcome). Reported scores for the HHS utilized the following grading: * \<70 = poor * 70 to 80 = fair * 80 to 90 = good * 90 to 100 = excellent
Outcome measures
| Measure |
Total Hip Arthroplasty
n=225 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Harris Hip Score (HHS)
60 Months
|
88.00 score on a scale
Standard Deviation 15.24
|
|
Harris Hip Score (HHS)
Pre-operative
|
48.60 score on a scale
Standard Deviation 11.55
|
|
Harris Hip Score (HHS)
3 Months
|
83.10 score on a scale
Standard Deviation 13.24
|
|
Harris Hip Score (HHS)
12 Months
|
89.20 score on a scale
Standard Deviation 12.71
|
|
Harris Hip Score (HHS)
36 Months
|
89.10 score on a scale
Standard Deviation 13.06
|
|
Harris Hip Score (HHS)
120 Months
|
85.30 score on a scale
Standard Deviation 14.92
|
SECONDARY outcome
Timeframe: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 MonthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
WOMAC Pain subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range of 0 to 20. Higher WOMAC scores indicate worse pain (i.e., worse outcome) and lower scores indicate less pain (i.e., a better outcome).
Outcome measures
| Measure |
Total Hip Arthroplasty
n=225 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale
Pre-operative
|
11.5 score on a scale
Standard Error 3.08
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale
3 Months
|
1.9 score on a scale
Standard Error 2.46
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale
12 Months
|
1.5 score on a scale
Standard Error 2.21
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale
36 Months
|
1.7 score on a scale
Standard Error 2.64
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale
60 Months
|
1.5 score on a scale
Standard Error 2.75
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale
120 Months
|
1.0 score on a scale
Standard Error 2.46
|
SECONDARY outcome
Timeframe: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 MonthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
WOMAC Stiffness subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range from 0 to 8 with a higher score indicating a worse outcome and a low score indicating a better outcome.
Outcome measures
| Measure |
Total Hip Arthroplasty
n=225 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale
36 Months
|
1.0 score on a scale
Standard Error 1.51
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale
60 Months
|
0.7 score on a scale
Standard Error 1.24
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale
120 Months
|
0.6 score on a scale
Standard Error 1.22
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale
3 Months
|
1.6 score on a scale
Standard Error 1.50
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale
12 Months
|
1.1 score on a scale
Standard Error 1.24
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale
Pre-operative
|
5.0 score on a scale
Standard Error 1.46
|
SECONDARY outcome
Timeframe: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 MonthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
WOMAC Physical Function subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range from 0 to 68 with a higher score indicating a worse outcome and a low score indicating a better outcome.
Outcome measures
| Measure |
Total Hip Arthroplasty
n=225 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale
Pre-operative
|
42.1 score on a scale
Standard Error 10.53
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale
3 Months
|
10.8 score on a scale
Standard Error 11.21
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale
12 Months
|
8.0 score on a scale
Standard Error 9.42
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale
36 Months
|
8.0 score on a scale
Standard Error 11.23
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale
60 Months
|
9.3 score on a scale
Standard Error 11.35
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale
120 Months
|
5.9 score on a scale
Standard Error 10.10
|
SECONDARY outcome
Timeframe: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 MonthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
WOMAC total score combines Stiffness, Pain, and Physical Function subscales of the Hip Disability and Osteoarthritis Outcome Score (HOOS) into a range from 0 to 96 with a higher score indicating a worse outcome and a lower score indicating a better outcome.
Outcome measures
| Measure |
Total Hip Arthroplasty
n=225 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score
Pre-operative
|
58.6 score on a scale
Standard Error 13.94
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score
3 Months
|
14.2 score on a scale
Standard Error 14.39
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score
12 Months
|
10.5 score on a scale
Standard Error 12.11
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score
36 Months
|
10.7 score on a scale
Standard Error 14.53
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score
60 Months
|
11.6 score on a scale
Standard Error 14.38
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score
120 Months
|
7.4 score on a scale
Standard Error 12.91
|
SECONDARY outcome
Timeframe: 3 months, 12 months, 36 months, 60 months, 120 monthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
Number of hips identified with radiographic findings of radiolucent lines present (Yes/No) in femoral zones 1 to 14. Radiolucent lines indicated seams of 0 millimeters to 2 millimeters or greater.
Outcome measures
| Measure |
Total Hip Arthroplasty
n=219 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Radiological: Radiolucent Lines
60 Months · No
|
165 hips
|
|
Radiological: Radiolucent Lines
120 Months · Yes
|
2 hips
|
|
Radiological: Radiolucent Lines
120 Months · No
|
62 hips
|
|
Radiological: Radiolucent Lines
3 Months · Yes
|
2 hips
|
|
Radiological: Radiolucent Lines
3 Months · No
|
217 hips
|
|
Radiological: Radiolucent Lines
12 Months · Yes
|
0 hips
|
|
Radiological: Radiolucent Lines
12 Months · No
|
215 hips
|
|
Radiological: Radiolucent Lines
36 Months · Yes
|
7 hips
|
|
Radiological: Radiolucent Lines
36 Months · No
|
183 hips
|
|
Radiological: Radiolucent Lines
60 Months · Yes
|
1 hips
|
SECONDARY outcome
Timeframe: 3 months, 12 months, 36 months, 60 months, 120 monthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
Number of hips identified with radiographic findings of osteolysis present (Yes/No) in femoral zones 1 to 14.
Outcome measures
| Measure |
Total Hip Arthroplasty
n=219 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Radiological: Osteolysis
3 Months · No
|
219 hips
|
|
Radiological: Osteolysis
12 Months · Yes
|
1 hips
|
|
Radiological: Osteolysis
12 Months · No
|
214 hips
|
|
Radiological: Osteolysis
36 Months · Yes
|
1 hips
|
|
Radiological: Osteolysis
36 Months · No
|
189 hips
|
|
Radiological: Osteolysis
60 Months · Yes
|
0 hips
|
|
Radiological: Osteolysis
60 Months · No
|
166 hips
|
|
Radiological: Osteolysis
120 Months · Yes
|
3 hips
|
|
Radiological: Osteolysis
120 Months · No
|
61 hips
|
|
Radiological: Osteolysis
3 Months · Yes
|
0 hips
|
SECONDARY outcome
Timeframe: 3 months, 12 months, 36 months, 60 months, 120 monthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
Number of hips identified with radiographic findings for atrophy in femoral zones 1 to 14 indicated as: * None * Mild * Moderate * Severe * Missing
Outcome measures
| Measure |
Total Hip Arthroplasty
n=219 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Radiological: Atrophy
3 Months · Mild
|
0 hips
|
|
Radiological: Atrophy
3 Months · Moderate
|
0 hips
|
|
Radiological: Atrophy
3 Months · Severe
|
0 hips
|
|
Radiological: Atrophy
3 Months · Missing
|
218 hips
|
|
Radiological: Atrophy
12 Months · None
|
0 hips
|
|
Radiological: Atrophy
12 Months · Mild
|
0 hips
|
|
Radiological: Atrophy
12 Months · Moderate
|
0 hips
|
|
Radiological: Atrophy
12 Months · Severe
|
0 hips
|
|
Radiological: Atrophy
12 Months · Missing
|
215 hips
|
|
Radiological: Atrophy
36 Months · None
|
1 hips
|
|
Radiological: Atrophy
36 Months · Mild
|
0 hips
|
|
Radiological: Atrophy
36 Months · Moderate
|
0 hips
|
|
Radiological: Atrophy
36 Months · Severe
|
0 hips
|
|
Radiological: Atrophy
36 Months · Missing
|
189 hips
|
|
Radiological: Atrophy
60 Months · None
|
0 hips
|
|
Radiological: Atrophy
60 Months · Mild
|
1 hips
|
|
Radiological: Atrophy
60 Months · Moderate
|
0 hips
|
|
Radiological: Atrophy
60 Months · Severe
|
0 hips
|
|
Radiological: Atrophy
60 Months · Missing
|
165 hips
|
|
Radiological: Atrophy
120 Months · None
|
0 hips
|
|
Radiological: Atrophy
120 Months · Mild
|
0 hips
|
|
Radiological: Atrophy
120 Months · Moderate
|
0 hips
|
|
Radiological: Atrophy
120 Months · Severe
|
1 hips
|
|
Radiological: Atrophy
120 Months · Missing
|
63 hips
|
|
Radiological: Atrophy
3 Months · None
|
1 hips
|
SECONDARY outcome
Timeframe: 3 months, 12 months, 36 months, 60 months, 120 monthsPopulation: All participants who received study treatment with data collected for the given outcome at the time point specified.
Number of hips identified with radiographic findings for hypertrophy in femoral zones 1 to 14 indicated as: * None * Mild * Moderate * Severe * Missing
Outcome measures
| Measure |
Total Hip Arthroplasty
n=219 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Radiological: Hypertrophy
3 Months · None
|
0 hips
|
|
Radiological: Hypertrophy
3 Months · Mild
|
0 hips
|
|
Radiological: Hypertrophy
3 Months · Moderate
|
0 hips
|
|
Radiological: Hypertrophy
3 Months · Severe
|
0 hips
|
|
Radiological: Hypertrophy
3 Months · Missing
|
219 hips
|
|
Radiological: Hypertrophy
12 Months · None
|
0 hips
|
|
Radiological: Hypertrophy
12 Months · Mild
|
0 hips
|
|
Radiological: Hypertrophy
12 Months · Moderate
|
0 hips
|
|
Radiological: Hypertrophy
12 Months · Severe
|
1 hips
|
|
Radiological: Hypertrophy
12 Months · Missing
|
214 hips
|
|
Radiological: Hypertrophy
36 Months · None
|
1 hips
|
|
Radiological: Hypertrophy
36 Months · Mild
|
0 hips
|
|
Radiological: Hypertrophy
36 Months · Moderate
|
0 hips
|
|
Radiological: Hypertrophy
36 Months · Severe
|
1 hips
|
|
Radiological: Hypertrophy
36 Months · Missing
|
188 hips
|
|
Radiological: Hypertrophy
60 Months · None
|
0 hips
|
|
Radiological: Hypertrophy
60 Months · Mild
|
1 hips
|
|
Radiological: Hypertrophy
60 Months · Moderate
|
0 hips
|
|
Radiological: Hypertrophy
60 Months · Severe
|
2 hips
|
|
Radiological: Hypertrophy
60 Months · Missing
|
163 hips
|
|
Radiological: Hypertrophy
120 Months · None
|
0 hips
|
|
Radiological: Hypertrophy
120 Months · Mild
|
1 hips
|
|
Radiological: Hypertrophy
120 Months · Moderate
|
0 hips
|
|
Radiological: Hypertrophy
120 Months · Severe
|
0 hips
|
|
Radiological: Hypertrophy
120 Months · Missing
|
63 hips
|
SECONDARY outcome
Timeframe: 3 months, 12 months, 36 months, 60 months, 120 monthsPopulation: All participants who received study treatment with data available for the given outcome at the time point specified.
Number of hips identified with radiographic findings associated with loosening of the implant or migration were indicated as: * Integration not assessable * Indifferent, bone unchanged * Osteointegration, integration * Bone loss * Signs of loosening * Revision indicated
Outcome measures
| Measure |
Total Hip Arthroplasty
n=219 hips
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Radiological: Loosening of the Implant or Migration
36 Months · Revision indicated
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
120 Months · Revision indicated
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
3 Months · Integration not assessable
|
4 hips
|
|
Radiological: Loosening of the Implant or Migration
3 Months · Indifferent, bone unchanged
|
138 hips
|
|
Radiological: Loosening of the Implant or Migration
3 Months · Osteointegration, integration
|
77 hips
|
|
Radiological: Loosening of the Implant or Migration
3 Months · Bone loss
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
3 Months · Signs of loosening
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
3 Months · Revision indicated
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
12 Months · Integration not assessable
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
12 Months · Indifferent, bone unchanged
|
81 hips
|
|
Radiological: Loosening of the Implant or Migration
12 Months · Osteointegration, integration
|
134 hips
|
|
Radiological: Loosening of the Implant or Migration
12 Months · Bone loss
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
12 Months · Signs of loosening
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
12 Months · Revision indicated
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
36 Months · Integration not assessable
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
36 Months · Indifferent, bone unchanged
|
67 hips
|
|
Radiological: Loosening of the Implant or Migration
36 Months · Osteointegration, integration
|
123 hips
|
|
Radiological: Loosening of the Implant or Migration
36 Months · Bone loss
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
36 Months · Signs of loosening
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
60 Months · Integration not assessable
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
60 Months · Indifferent, bone unchanged
|
104 hips
|
|
Radiological: Loosening of the Implant or Migration
60 Months · Osteointegration, integration
|
62 hips
|
|
Radiological: Loosening of the Implant or Migration
60 Months · Bone loss
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
60 Months · Signs of loosening
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
60 Months · Revision indicated
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
120 Months · Integration not assessable
|
0 hips
|
|
Radiological: Loosening of the Implant or Migration
120 Months · Indifferent, bone unchanged
|
22 hips
|
|
Radiological: Loosening of the Implant or Migration
120 Months · Osteointegration, integration
|
40 hips
|
|
Radiological: Loosening of the Implant or Migration
120 Months · Bone loss
|
2 hips
|
|
Radiological: Loosening of the Implant or Migration
120 Months · Signs of loosening
|
0 hips
|
Adverse Events
Total Hip Arthroplasty
Serious events: 114 serious events
Other events: 115 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Total Hip Arthroplasty
n=218 participants at risk
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Inpatient geriatric for asthma, no relationship to study device
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
AV fistula after cardiac catheter right groin
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Bladder cancer
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Breakage of inlay due to recurrent falls due to M. Parkinson
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Cage-implantation L3/L4
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Eye disorders
Cataract surgery on both sides
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Cervical spine surgery 2017
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Cholecystectomy
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic bronchitis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Chronic kidney insufficiency
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Chronic renal failure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Colon tumour
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Condition after herniated cervical spine
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Condition after herniated disc LWK1
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Condition after knee TEP on the left (no complaints currently)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Contralateral hip TEP
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Contralateral Hip treated with TEP to explain LLD 8mm
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
1.4%
3/218 • Number of events 3 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Coronary 2-vessel disease PAVK II bilateral
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Coronary Heart Disease
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Coronary stent
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Cup fixation
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Cup revision after dislocation
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death
|
1.4%
3/218 • Number of events 3 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death - Death not caused or contributed to misuse of the study device
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Death due to abdominal surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to cancer
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Death due to cardiac failure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Reproductive system and breast disorders
Death due to cervic carcinoma
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to multiple myeloma
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death due to old age - no relationship to study device
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Hepatobiliary disorders
Death due to pancreatic cancer
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Death due to suicide
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Injury, poisoning and procedural complications
Death due to traffic accident
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Death -Exitus letalis for pulmonary bleeding
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death, cause not related to hip surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death. Cause of death and information about prosthesis are not available
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death. Cause of death is unknown
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death. Cause of death unknown. Polarstem in situ.
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death. Not related to hip surgery
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death. Not related to the study procedure. The cause of death is unknown
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death. Polarstem in situ. Cause of death unknown
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death. Reason unknown
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death. Reason unknown. Prosthesis in situ.
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Death: ARDS, no relation to study process visible
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death: Hip in situ. Cause of death is unknown
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Death: Hip in situ. No further information available on the cause of death
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Death: stroke
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Blood and lymphatic system disorders
Deep vein thrombosis and subarachnoid haemorrhagic bleeding
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative thoracic spine syndrome (secondary diagnosis documented)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Endocrine disorders
Diabetes
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Endocrine disorders
Diabetes (secondary diagnosis documented)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Endocrine disorders
Diabetes II
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Endocrine disorders
Diabetes mellitus
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Endocrine disorders
Diabetic mellitus with polyneuropathy
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Disclocation closed reposition
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Dislocation (Luxation)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Infections and infestations
Early infection
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Early infection, septic revision
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Infections and infestations
Erysipelas right lower leg
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Excision of leukoplakia right soft palate
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Exitus letalis: eCPR due to cardiac arrest
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Foot surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Foot surgery hallux valgus left - no relationship to study device
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Fracture and WK replacement C5 in 2012. Fracture C6/7 in 1997
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance most likely due to normal pressure hydrocephalus
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain, unclear aetiology left hip without organic cause
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Heart attack
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Heart failure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Hemiparesis right leg with force grade 4/5.
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Hip prosthesis left
|
2.3%
5/218 • Number of events 5 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Hip prosthesis right (opposite side) no relationship to study device
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Hip replacement right
|
2.8%
6/218 • Number of events 6 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Hip TEP
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Hip TEP contralateral side, left, , age-related not related to study hip.
|
1.8%
4/218 • Number of events 4 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Hip TEP left, Implantation due to coxarthrosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Hip TEP. Non-study hip. Age-related not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
HKB crack right 08'18. No association to the study procedure.
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Hospitalisation
|
1.4%
3/218 • Number of events 3 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalisation due to Bronchitis and Cholezystolithiasis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Hospitalisation due to chronic low back pain
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Hospitalisation for Artial Fibrillation
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Hospitalisation. Inpatient due to acute psychosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Infections and infestations
Hospitalisation: infection after knee TP
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Hospitalised for myocardial infarction
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Humerus subcapital fracture, no visible connection to study procedure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Reproductive system and breast disorders
Hysterectomy
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Reproductive system and breast disorders
Hystorectomy. No association to the study procedure.
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Implantation of hip replacement surgery Li
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Implantation of neurostimulator in lumbar spine
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Inlay loosening, malfixation during surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Inpatient conservative therapy in a hospital
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Inpatient geriatric for dementia, no relationship to study device
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Intervetebral disc surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Intestinal Obstruction (Ileus) with adhesions with surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
s/p hip TEP left
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Hepatobiliary disorders
Secretion in liver
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Semantic dementia first diagnosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder surgery, partial rotator cuff rupture right
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder TEP, left side, date unknown, not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder TEP. Not related to study procedure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Shunt implantation for normal pressure hydrocephalus
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Sintering fracture of a lumbar vertebra
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spinal surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spinal surgery after a herniated disc
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spine/inpation treatment for lumbar disease
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spondylectomy L1-S1
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Hepatobiliary disorders
Steatosis hepatis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Suspected fissural tibial shaft fracture
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
THA left (non-study hip)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Thoracic spine fracture (BWS-12), traumatic brain injury
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Three-vessel disease
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Endocrine disorders
Thyroid carcinoma. No association with the study process visible
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
TIA left hemisphere
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
TKA
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Total hip replacement on left side
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Endocrine disorders
Type 2 diabetes mellitus
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Ulnar and radius fracture. Pre-existing condition
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Varicosis OP. No association with the study process visible
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
VHF arterial fibrillation (medication)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Walking affected due to hip TEP on both sides
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Hepatobiliary disorders
Z. n. Pancreas cancer
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Z.n. acute kidney failure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Z.n. bypass right leg
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Z.n. decompression lumbar spine
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Z.n. herniated disc
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Z.n. Pneumonia bilateral
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Z.n. Pulmonary embolism with thrombosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Blood and lymphatic system disorders
Z.n.TBVT li
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Hepatobiliary disorders
Metastasis liver
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Myocardial infarction
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Quadruple Heart bypass
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Abdominal Surgery due to Bridenileus - no relationship to study device
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Poor general condition
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
ACI stenosis on both sides
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Additional abdominal surgery due to adhesions
|
0.46%
1/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Skin and subcutaneous tissue disorders
Amputation of the small toe on the right due to melanoma
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Ankle arthrodesis on the right
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Apoplexy
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Articulated flat splayfoot on the left, insoles adapted
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
July 2019 facet joint surgery spinal stenosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee prosthesis right
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee replacement - left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee replacement - right
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP bilateral (date unknown), age-related not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP both sides
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP due to progressive pain
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP on both sides
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP right
|
2.3%
5/218 • Number of events 6 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP right date unknown, age-related not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP right due to gonarthrosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP right side
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP right side, date unknown, not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP right. Age-related not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee total replacement left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Left gonarthrosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Left hip prosthesis (non-study hip)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Left hip TEP (non-study hip)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Left hip TEP, Primary coxarthroses
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Leg length difference compensated accoridng to patient information
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Length discrepancy corrected with shoe insole
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Infections and infestations
Local infection
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Long biceps tendon tear
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung cancer
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung embolism after study procedure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Lung surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Reproductive system and breast disorders
Mammary carcinoma
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Massive pain due to functional limitation of non study hip (Coxarthrose contralateral side)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Mental problems
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Numbness since surgery in 4.and 5. toe and outer side of the left foot.
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Operation in esophagus CA
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Opiate and benzodiazepine addiction
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
OSAS with CPAP
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis left knee, right hip. No association with the study process visible
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Pain after stent surgery in the area of arteria iliaca externa
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial cancer (NSCLC)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Perforated stomach ulcer (malign)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Peripheral artery disease bilateral with percutaneous transluminal angioplasty (PTA) left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Periprosthetic femoral fracture left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Peroneus partial palsy left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion Jan 2016, Pleurodesis 15.06.2016
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Polineuropathy
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Possible trochanteric fracture after a fall
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Postoperative failure of kidney implant. High Crea 3,3mg/dl
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Prostate cancer
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Proximal high grade stenosis in tracheomalacia
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Radial fracture
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Removal of haematoma after falling right thigh
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Renal failure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Re-operation head change and inlay change
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Restriction due to spinal stenosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Right forearm fracture
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Right knee TEP, with complaints
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff rupture on both sides - no evidence of a connection with study procedure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Eye disorders
s/p cataract surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Eye disorders
s/p detached retina with eye surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
s/p disc prolapse surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
s/p disc prolapse surgery. No relation to study procedure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
s/p fracture of the shoulder
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
Other adverse events
| Measure |
Total Hip Arthroplasty
n=218 participants at risk
Total Hip Arthroplasty using Cementless version of the POLARSTEM
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Condition after bursitis of the thighs on both sides
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD with continuous oxygen administration
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Coronary heart disease
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Coxarthrosis on the left, SIG arthrosis on both sides
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Cramp-like pain on prolonged exposure in the lateral thigh
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Decubitus Heel
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Demolition d. major trochanter tip in the process of being resorbed
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Depression
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Endocrine disorders
Diabetis mellitus regulation disorder
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Disc prolapse cervical spine
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Disc prolapse in lumbar spine
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Disc prolapse in the L4/L5 area
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Dizziness
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Skin and subcutaneous tissue disorders
Early complications: pressure ulcers. 1st degree on the sacrum
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Extreme knee and back pain. Condition after a five-fold herniated disc
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Fall on both hips ~3 months ago
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Fall on the hip twice
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Fall. Stabbing groin pain since then
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Gastritis (not related to study procedure)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
GIST des sigmas with sigma resection
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Gluteal muscle weakness on the left (opposite side) unclear cause
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis bilateral
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
gonarthrosis left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis on both sides of the lower back pain
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis right
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis right , causes discomfort
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis right and left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Head pain due to back complaints
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Heart failure DD: TAA
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Heart failure NYHA III
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Herniated Disc
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
herniated disc lumbar spine with stiffening
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Infections and infestations
Herpes Zoster (previously known, now recurrence post-op)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Hip pain partly on right, partly on left, partly due to foot pain
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Hypertension
|
4.6%
10/218 • Number of events 10 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Ignition of the other hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Incontinence
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Internal problems. Hips do not cause problems
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Jumping of the tractus ibiotibialis (coxa saltans)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Kidney insufficiency
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Patient has back problems
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Patient has had stomach problems
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee pain left - no relationship to study device
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee problems
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee problems left side, age-related not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Knee TEP left
|
0.46%
1/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Left hip (not study hip) pain, needs to be replaced
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Left hip causes problems but no diagnosis available
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Left hip pain
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
left hip problems for 3 years (only medication)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Left hip TEP (non-study hip) still complaints, leg length difference due to TEP on the left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Limitation of walking distance
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Local swelling and redness with puncture without evidence of pathogens
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Skin and subcutaneous tissue disorders
Lower leg wound after trauma
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar sciatica. Spinal canal sterosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spine complaints due to slight lumbar spinal stenosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spine discomfort
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Lymphedema bilateral varicosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Lymphoedema left leg 2017
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Mild spinal stenosis of the lumbar spine- lumbar spine stenosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Mitral insufficiency
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Multiple herniated discs
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Muscular pain
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Myositis ossificans
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Nerve paralysis, siatic nerve lesion
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Nerve paralysis, weakness of the peroneus, already regressing at discharge
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnea syndrome
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Occasional hip pain (study hip)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis in large joints
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pain both knees
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pain from time to time in both knees
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pain in knee
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pain in knee joint after knee TEP
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pain in the contralateral hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pain in the right groin
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pain right knee, age-related not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pain right shoulder
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Painkillers for back pain, spondylarthrosis herniated disc
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Painkillers for pain in lumbar spine
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Feeling of uncertainty during walk
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis trochanterica
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Can walk stairs and ascents very poorly due to muscular insufficiency. Avoids standing for long time
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Cardiac insufficiency
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Cardiovascular disturbances
|
2.3%
5/218 • Number of events 5 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Cholecystolithiasis (not related to study procedure)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Chronic gastric ulcer
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Absolute arrhythmia atrial fibrillation
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Addiction syndrom
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Advanced right coxarthrosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Aortic insufficiency
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Aortic stenosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Arterial hypertension
|
3.7%
8/218 • Number of events 8 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis in feet
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Arthrosis left knee
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Arthrosis left talocrural joint (OSG) no surgery
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Arthrosis LWK 4 & 5
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Arthrosis. No relation to study procedure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
8/218 • Number of events 8 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Back pain due to obesity and age-related not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Bladder catheter
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Blood and lymphatic system disorders
Bleeding tendency (blood loss 1.5L)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial asthma
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Bruised ribs
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Patient slipped. 6 weeks groin pain right side, 03.08.2016-09.2016
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Patient was in general not very satisfied
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
pAVK right, reason for more pain
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Blood and lymphatic system disorders
Perioperative Anemia
|
4.6%
10/218 • Number of events 10 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Peripheral artery disease
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Phlebolymphedema
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Polyarthrosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Polyneuropathy
|
1.4%
3/218 • Number of events 3 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Poor general condition, no relationship to study device
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Poor general condition. Patient with dementia. Polarstem in situ
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Poor general health condition
|
1.4%
3/218 • Number of events 4 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Poor general health condition, psychiatric disorders
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Blood and lymphatic system disorders
Postoperative anemia
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pressure pain medial tibial head with knee prosthesis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Progressive complaints in various areas of Musculoskeletal & connective tissue disorders
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Pronounced coxarthrosis on the right
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Prosthesis in situ. Patient reports minimal discomfort
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Pseudomembranous colitis (not related to study procedure)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Psychiatric disorders
Recurrent depressive disorder
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Reflux
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Hepatobiliary disorders
resection of a liver metastasis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Restless Leg Syndrom
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Right hip problems due to obesity and age-related. Not related to study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Right knee pain now and then
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Right tronchanteric bursitis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Rollator since 4 years due to MS
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
s/p meniscuc lesion left 2017. No relation to study procedure
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
s/p pericardial effusion
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
s/p rotator cuff rupture left
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
s/p rotator cuff rupture right
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Schmerzen in der Wirbelsaeule
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Seroma drainage post-op
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
severe pain and swelling in right knee (Gonarthrosis)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Skin and subcutaneous tissue disorders
Shingles
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Since 4 months problems with spinal discs causing pain in non study hip
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Slight coxarthrosis on the left (non study hip)
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Small intestine passage disorder
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spinal canal stenosis and thus back pain
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spinal canal stenosis lumbar spine
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spinal canal stenosis of the cervical and lumbar spine
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spinal discomfort
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spondylarthrosis lumbar spine
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Spondylosis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Stiffening of contralateral hip joint
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Syncope
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Torn tendon on shoulder
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Cardiac disorders
Tricuspid insufficiency
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Tronchanteric bursitis
|
3.7%
8/218 • Number of events 8 • Surgery to End of Study visit, approximately 120 months
|
|
Gastrointestinal disorders
Upper abdominal complaints
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Ureteritis
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Renal and urinary disorders
Urinary tract infection
|
0.92%
2/218 • Number of events 2 • Surgery to End of Study visit, approximately 120 months
|
|
General disorders
Vitamin B12 deficiency
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Musculoskeletal and connective tissue disorders
Wobbly knee
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Immune system disorders
Wound dressing allergy
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
|
Nervous system disorders
Z.n. Cerebral hemorrhage in 2008 with subsequent shunt implantation
|
0.46%
1/218 • Number of events 1 • Surgery to End of Study visit, approximately 120 months
|
Additional Information
Director Clinical Operations - EU
Smith + Nephew plc
Phone: 00441923 477100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place