DePuy PMCF Studies

US ASR XL DOTS Registry

14 centres

I 455 hips (ASR XL implanted FEB 2006 - JAN 2010)

I Gender: Male 204 hips; Female 251 hips

I Mean follow-up 2.23 years (range 0.0 - 5.12 years)

38 revision (8.4%)

APPEARED TO BE HYPERSENSITIVITY TO THE METAL 1 INFECTION 5

ASEPTIC LOOSENING 7 METAL ON METAL WEARASR 1

ASR 1 METAL ON METAL WEAR REVISED CUP 1

ASR METAL METAL DISEASE 2 METAL SENSITIVITY 1

ASR RECALL 2 NON SPECIFIED 2

DISLOCATION 2 PAIN, FLUID COLLECTION, HIGH ION LEVELS 1

ELEVATED BLOOD COBALT/CHROMIUMLEVELS 2 PAIN/STIFFNESS 3

FAILED DEPUY ASR HIP 2 PERIPROSTHETIC FRACTURE 1

IMPLANT FAILURE 1 POST-OPDISLOCATIONDUE TO FALL 1

IMPLANT FRACTURE 1 SQUEAKING & PAIN ASRHIP 1

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DOTS ASR·XL THA Survivorship Kaplan-Meier Survivorship

Event=Failure Any Reason (N=455)

100---~_~~

Q) 80 16 E 70

m 60

10) 50 .~ -.....-_----.......------.......-_ ........ ::J 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 rj)

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 ASR·XL THA Survivorship Kaplan -Meier Survivorship Across Time

Survival Estimate 100.0 99.8 99.8 98.7 98.4 97.1 92.8 90.5 87.2 70.5

Lower 95% Confidence Limit 100.0 98.2 98.2 96.7 96.2 94.2 88.6 85.7 81.3 58.0

Upper 95% Confidence Limit 1000 1000 100.0 99.5 99.3 98.5 95.5 93.8 91.4 79.8

Hips Remaining 455 356 323 288 263 215 173 138 80 28 <20

Cumulative Hips Revised o 4 5 8 17 21 25 34 38

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DePuy PMCF Studies US 04062 ASR XL

9 centres

• 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 1

PAIN 1

ELEVATED COBALT LEVELS 1

GROIN PAIN 1

INFECTION 1

LOOSENING 1

METAL REACTION 3

METAL SENSITIVnY 1

PAIN 1

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100

~ ~ ....... 90

Q) 80 10 E 70

~ 60 -~ 50 .~

:l 0.0 00

0.5

04062 ASR-XL THA Survivorship Kaplan-Meier Survivorship

Event=Failure Any Reason (N=130)

L.."

I I I

1.0 1.5 2.0 2.5 3.0 3.5

Tme (Years)

treatment -I

I

4.0

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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4.5 5.0

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04062 ASR-XL THA Survivorship Kaplan -Meier Survivorship Across Time

Survival Estimate 100.0 99.2 99.2 99.2 99.2 96.8 94.1 91.6

Lower 95% Confidence Limit 100.0 94.4 94.4 94.4 94.4 90.3 86.3 81.2

Upper 95% Confidence Limit 1000 99.9 99.9 99.9 99.9 99.0 97.6 96.4

Hips Remaining 130 122 117 108 100 80 58 34 <20

Cmnulative Hips Revised o 1 3 567

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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 ON METAL WEARASR METAL 1

METAL ON METAL WEAR REVISED CUP ASEPTIC LOOSENING 7

METAL REACTION ASR 1

METAL SENSITIVITY ASR METAL METAL DISEASE 2

NnJSCULOSKELETAL ASRRECALL 2

NON SPECIFIED DISLOCATION 2

ELEVATED BLOOD COBAL T/CHROMIUM LEVELS 2 NOT RECORDED

PAIN ELEVATED COBALT LEVELS 1

FAILED DEPUY ASR HIP 2 PAIN, FLUID COLLECTION, HIGH ION LEVELS

GROIN PAIN 1 P AINISTIFFNESS

IMPLANT FAILURE 2 PERIPROSTHETIC FRACTURE

INFECTION 6 POST-OP DISLOCATION DUE TO FALL

LOOSENING 1 SQUEAKING & PAIN ASR HIP

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3

2

2

3

1

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Q) 80 15 E ~ 70

~ 60

DOTS and 04062 ASR·XL THA Survivorship Kaplan-Meier Survivorship

Event=Failure Any Reason (N=554)

ta > 50~~ ______________ ~ __ ~~ __ ~~ __

~ ::J 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 (j)

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 ASR·XL 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

Lower 95% Confidence Limit 100.0 98.3 98.3 97.1 96.7 94.3 89.1 86.1 81.1 53.3

Upper 95% Confidence Limit 100.0 99.9 99.9 99.5 993 98.2 95.2 93.3 90.6 75.3

Hips Remaining 554 451 413 370 339 276 220 163 88 27 <20

Cumulative Hips Revised o 2 2 5 6 11 22 27 32 45 49

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