Warning Issued on MoM Implants

Smith & Nephew issued an “Urgent Field Service Notice” for its Birmingham Hip Modular Head Implants after new data suggested that the metal-on-metal hip (MOM) implant has a higher failure rate than recommended by a British health agency.

The hip implants involved are not approved for use in primary hip replacements in the U.S., according to Mass Device.

Smith & Nephew’s notice says new data from the National Joint Registry of England and Wales suggests that the implants have a 1.29 percent failure rate. In addition, the Australian Orthopaedic Association’s National Joint Replacement Registry puts the failure rate of the devices at 1.12 percent. Smith & Nephew says those rates surpass the 1 percent failure rate set by the U.K.’s National Institute for Health and Clinical Excellence.

A recall on the device has not been issued. Instead, the company updated the instructions for its use.  According to Smith & Nephew, when the implants are used with the company’s Synergy stems, the failure rate becomes 1.07 percent, which is within acceptable limits.

The revised “indications for use” on the Birmingham Hip Modular Heads limit the device to revision surgeries where a Birmingham Hip Resurfacing femoral component is being revised, as stated on the Smith & Nephew web site. The patient also should not exhibit metal sensitivity and the device should be implanted in conjunction with an uncemented Synergy stem.

Metal-on-metal hip implants have garnered thousands of patient complaints, led to revision surgeries, and unleashed a raft of lawsuits upon medical device manufacturers such as DePuy, Stryker, and others.

If you or someone you know has been harmed by an unsafe medical device, contact Sokolove Law for a free consultation and to find out if a product liability lawyer may be able to help you.

Tags: