Podcast
Questions and Answers
What clearance process allowed the ASR XL total hip replacement to be marketed without clinical trials?
What clearance process allowed the ASR XL total hip replacement to be marketed without clinical trials?
Which institution conducted in vitro wear testing on the ASR resurfacing at 55° inclination?
Which institution conducted in vitro wear testing on the ASR resurfacing at 55° inclination?
What is the average wear of ASR resurfacing explants per year?
What is the average wear of ASR resurfacing explants per year?
How many steps do resurfacing patients do per year on average?
How many steps do resurfacing patients do per year on average?
Signup and view all the answers
What is the reported result from laboratory wear testing of the ASR XL total hip replacement?
What is the reported result from laboratory wear testing of the ASR XL total hip replacement?
Signup and view all the answers
Who is responsible for the post-market surveillance of the ASR XL total hip replacement?
Who is responsible for the post-market surveillance of the ASR XL total hip replacement?
Signup and view all the answers
What testing process did the ASR XL total hip replacement undergo prior to being fitted by surgeons?
What testing process did the ASR XL total hip replacement undergo prior to being fitted by surgeons?
Signup and view all the answers
What noteworthy feature characterizes the ASR resurfacing wear testing at 55° inclination compared to large ASRs at 45°?
What noteworthy feature characterizes the ASR resurfacing wear testing at 55° inclination compared to large ASRs at 45°?
Signup and view all the answers
'Substantial equivalence' is a concept closely related to which regulatory approval process in the United States?
'Substantial equivalence' is a concept closely related to which regulatory approval process in the United States?
Signup and view all the answers
'Revision rates' in the context of metal-on-metal hips refer to what specific aspect?
'Revision rates' in the context of metal-on-metal hips refer to what specific aspect?
Signup and view all the answers
