DePuy PMCF Studies

US ASR XL DOTS Registry 14 centres

I

455 hips (ASR XL implanted FEB 2006 - JAN 2010) Gender: Male 204 hips; Female 251 hips Mean follow-up 2.23 years (range 0.0 - 5.12 years)

38 revision (8.4%)
APPEARED TO BE HYPERSENSITIVITY TO THE METAL 1 ASEPTIC LOOSENING ASR ASR METAL METAL DISEASE ASR RECALL DISLOCATION ELEVATED BLOOD COBALT/CHROMIUMLEVELS FAILED DEPUY ASR HIP IMPLANT FAILURE IMPLANT FRACTURE 7 1 2 2 2 2 2 1 1 INFECTION METAL ON METAL WEARASR METAL ON METAL WEAR REVISED CUP METAL SENSITIVITY NON SPECIFIED PAIN, FLUID COLLECTION, HIGH ION LEVELS PAIN/STIFFNESS PERIPROSTHETIC FRACTURE POST-OPDISLOCATIONDUE TO FALL SQUEAKING &PAIN ASRHIP 5 1 1 1 2 1 3 1 1 1

SRR5395

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DOTS ASRXL THA Survivorship

Kaplan-Meier Survivorship Event=Failure Any Reason (N=455)
100---~_~~

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4.5

5.0

5.5

6.0

Time (Years)
treatment I

SAS/Macros SUl1ivorship.sas . Run on Ftiday, 16SEP20 11, at 07:30

Survival Estimate at 4.57 Years is 64.2 %. Survival 95% Lower Confidence Level: 50.46 % Survival 95% Upper Confidence Level: 75.68 %
#of Hips at risk at 4.57 Years is 20.
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DOTS ASRXL THA Survivorship

Kaplan -Meier Survivorship Across Time

Survival Estimate Lower 95% Confidence Limit Upper 95% Confidence Limit Hips Remaining Cumulative Hips Revised

100.0 99.8 99.8 98.7 98.4 97.1 92.8 90.5 87.2 70.5 100.0 98.2 98.2 96.7 96.2 94.2 88.6 85.7 81.3 58.0 1000 1000 100.0 99.5 99.3 98.5 95.5 93.8 91.4 79.8 455 356
323 288 263 215 173 138 80
4 5 8 17

28

<20

21

25

34

38

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DePuy PMCF Studies

US 04062 ASR XL 9centres 130 hips (ASR XL implanted NOV 2006 - DEC 2009) Gender: Male 70 hips; Female 60 hips Mean follow-up 2.63 years (range 0.06 - 4.76 years) 11 revision (8.5%)

MUSCULOSKELETAL PAIN ELEVATED COBALT LEVELS GROIN PAIN INFECTION LOOSENING METAL REACTION METAL SENSITIVnY PAIN

1 1 1 1 1 1 3 1 1

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04062 ASR-XL THA Survivorship

Kaplan-Meier Survivorship Event=Failure Any Reason (N=130)
100
~ ~ ....... 90
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10

80 70 60 50
I I I I I I

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2.5

3.0

3.5

4.0

4.5

5.0

Tme (Years)
treatment
-I

SASlMacros Survivorship.sas -Run on Friday, 16SEP2011, at 07:31

Survival Estimate at 3.92 Years is 91.59 %. Survival 95% Lower Confidence Level: 81.16 % Survival 95% Upper Confidence Level: 96.37 %
#of Hips at risk at 3.92 Years is 20.
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04062 ASR-XL THA Survivorship

Kaplan -Meier Survivorship Across Time

Survival Estimate Lower 95% Confidence Limit Upper 95% Confidence Limit Hips Remaining Cmnulative Hips Revised

100.0 99.2 99.2 99.2 99.2 96.8 94.1 91.6 100.0 94.4 94.4 94.4 94.4 90.3 86.3 81.2 1000 99.9 99.9 99.9 99.9 99.0 97.6 96.4 130 122 117 108 100 80 58 34 <20

567

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DePuy PMCF Studies

US ASR XL DOTS Registry and 04062 ASR XL 23 centres 554 hips (ASR XL implanted FEB 2006 - JAN 2010)

Gender: Male 256 hips; Female 298 hips Mean follow-up 2.23 years (range 0.0 - 5.12 years)
49 revision (8.8%)
APPEARED TO BE HYPERSENSITIVITY TO THE METAL ASEPTIC LOOSENING ASR ASR METAL METAL DISEASE ASRRECALL METAL ON METAL WEARASR
1

METAL ON METAL WEAR REVISED CUP METAL REACTION METAL SENSITIVITY NnJSCULOSKELETAL NON SPECIFIED NOT RECORDED PAIN PAIN, FLUID COLLECTION, HIGH ION LEVELS P AINISTIFFNESS PERIPROSTHETIC FRACTURE POST-OP DISLOCATION DUE TO FALL SQUEAKING &PAIN ASR HIP
3
1

7
1

2 2

2 DISLOCATION ELEVATED BLOOD COBALT/CHROMIUM LEVELS 2

ELEVATED COBALT LEVELS FAILED DEPUY ASR HIP GROIN PAIN IMPLANT FAILURE INFECTION LOOSENING

2
1

2 6
1

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DOTS and 04062 ASRXL THA Survivorship

Kaplan-Meier Survivorship Event=Failure Any Reason (N=554)

E ~
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0.0

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1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

6.0

Tme (Years)
treatment

SAS/Macros SUf'v1vorship.sas -Run on Friday, 16SEP2011, at 09:43

Survival Estimate at 4.57 Years is 63.0 %. Survival 95% Lower Confidence Level: 50.22 % Survival 95% Upper Confidence Level: 73.41 %
#of Hips at risk at 4.5 Years is 20.
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DOTS and 04062 ASRXL THA Survivorship

Kaplan -Meier Survivorship Across Time

Survival Estimate

100.0 99.6 99.6 98.8 98.5 96.8 92.7 90.3 86.6 65.6 100.0 98.3 98.3 97.1 96.7 94.3 89.1 86.1 81.1 53.3 100.0 99.9 99.9 99.5 993 98.2 95.2 93.3 90.6 75.3

Lower 95% Confidence Limit Upper 95% Confidence Limit

Hips Remaining Cumulative Hips Revised

554

451 413 370 339 276 220 163 88 2 2 5 6 11 22 27 32

27 45

<20 49

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