Metal-On-Metal Hips Get Failing Grade In New Registry Analysis
This article was originally published in The Gray Sheet
Devices were linked to a notably higher five-year revision rate compared to metal-on-polyethylene or ceramic-on-ceramic hips in an analysis of more than 400,000 implants. Recalled J&J/DePuy ASR devices were not included in the analysis.
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US FDA Nov. 20 announced plans for a broad series of updates to its Medical Device Safety Action Plan for the next several months, with the goal that FDA "is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.
This is the first win for patients and the second case to go to trial of more than 7,000 complaints against DePuy Orthopedics filed nationwide alleging the metal-on-metal version of the Pinnacle artificial hip broke prematurely and required resurfacing.
A final order from FDA calls for manufacturers to submit PMAs or take their metal-on-metal hip devices off the market by May 18. The widely anticipated move is part of a broader response to elevated adverse event rates tied to the products.