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Metal-on-Metal Hip Implants: Ancestry and Regulatory Clearance Quiz

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Metal-on-Metal Hip Implants: Ancestry and Regulatory Clearance Quiz

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Questions and Answers

What clearance process allowed the ASR XL total hip replacement to be marketed without clinical trials?

Post-market surveillance

In vitro wear testing

510(k) clearance (correct)

Pre-clinical testing

Which institution conducted in vitro wear testing on the ASR resurfacing at 55° inclination?

BSI

Leeds University (correct)

DePuy

Arthroplasty registers

What is the average wear of ASR resurfacing explants per year?

18mm3/year (correct)

90mm3/year

55mm3/year

9mm3/year

How many steps do resurfacing patients do per year on average?

1.9 million steps p.a. (C) Signup and view all the answers

What is the reported result from laboratory wear testing of the ASR XL total hip replacement?

$73,605*$ implanted worldwide with no reports of failures (C) Signup and view all the answers

Who is responsible for the post-market surveillance of the ASR XL total hip replacement?

DePuy (B) Signup and view all the answers

What testing process did the ASR XL total hip replacement undergo prior to being fitted by surgeons?

Pre-clinical in vitro tests (C) Signup and view all the answers

What noteworthy feature characterizes the ASR resurfacing wear testing at 55° inclination compared to large ASRs at 45°?

$90x$ more wear observed per cycle (D) Signup and view all the answers

'Substantial equivalence' is a concept closely related to which regulatory approval process in the United States?

'510(k)' clearance process (B) Signup and view all the answers

'Revision rates' in the context of metal-on-metal hips refer to what specific aspect?

$Y$-year post-implantation failure rates (D) Signup and view all the answers