PMAs Are The New Reality For Metal-On-Metal Hips
This article was originally published in The Gray Sheet
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.
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The company’s Ethicon business unit was cleared on allegations a pelvic mesh product had injured a Texas woman, while a jury in a separate trial issued a $247m award to patients claiming injury from the DePuy Orthopaedics Pinnacle hip.
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 planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.