MHRA Issues Warning for R3 Metal Cup Liner

The MHRA, the UK’s drug and medical device regulator, issued new advice to surgeons after Smith & Nephew’s recall of the R3 metal cup liner, a device used in some metal-on-metal hip replacement operations.

The MHRA warns that post-market surveillance data on the R3 metal cup liner reveals it has a revision rate of 6.3 percent at four years. This high revision rate is not in line with the 4 percent guidance figure from the National Institute of Health and Clinical Excellence.

As a result, the MHRA is urging surgeons to stop using the R3 metal cup liner. The MHRA also told surgeons to annually monitor the 281 patients who have been fitted with these cup liners so that any complications such as pain or swelling are picked up and treated early, according to a press release by the agency.

Updated advice was also issued by the agency telling surgeons to extend the period of follow-up monitoring of patients experiencing complications from their metal-on-metal hip implants that have a head diameter below 36 millimeters. In the past, the recommendation had been to follow such patients for a minimum of five years.

If you or a loved one has been harmed by a hip implant or another unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.

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