10 Questions
What clearance process allowed the ASR XL total hip replacement to be marketed without clinical trials?
510(k) clearance
Which institution conducted in vitro wear testing on the ASR resurfacing at 55° inclination?
Leeds University
What is the average wear of ASR resurfacing explants per year?
18mm3/year
How many steps do resurfacing patients do per year on average?
1.9 million steps p.a.
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
Who is responsible for the post-market surveillance of the ASR XL total hip replacement?
DePuy
What testing process did the ASR XL total hip replacement undergo prior to being fitted by surgeons?
Pre-clinical in vitro tests
What noteworthy feature characterizes the ASR resurfacing wear testing at 55° inclination compared to large ASRs at 45°?
$90x$ more wear observed per cycle
'Substantial equivalence' is a concept closely related to which regulatory approval process in the United States?
'510(k)' clearance process
'Revision rates' in the context of metal-on-metal hips refer to what specific aspect?
$Y$-year post-implantation failure rates
Test your knowledge on the regulatory clearance process and historical background of metal-on-metal hip implants, focusing on the ASR XL implant and related medical devices. Explore key findings from academic research and regulatory bodies in this quiz.
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