Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

PMAs Are The New Reality For Metal-On-Metal Hips

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...



J&J Wins Mesh Case, But Slammed With $247m Penalty On Hips

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.

J&J Ordered To Pay $502 Million In Hip Suit

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.

Planning Board Proposes Postmarket Device Surveillance Timeline

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.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034977

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel