Biomet Magnum Hip Recall Should Have Been Issued, Lawsuit Alleges

According to allegations raised in a recent product liability lawsuit brought over the Biomet M2A-Magnum Hip System, the manufacturer was aware of problems with the metal-on-metal hip replacement prior to the plaintiff’s surgery and should have recalled the system or stopped selling the device.

The complaint (PDF) was filed by Joanna McCoy and Kenneth Burgwin on May 11, in the U.S. District Court for the District of Maryland.

According to the lawsuit, McCoy received a Biomet Magnum to replace her right hip on December 6, 2007. However, by March 2009 she was suffering severe pain and in May 2010, doctors had to remove the implant as a result of indications the Biomet Magnum was coming loose. Following revision surgery, McCoy eventually had to have her left hip replaced due to all of the pressure placed on that hip because of the problems caused by the Biomet Magnum.

The Biomet M2a Magnum Hip is a metal-on-metal artificial hip replacement system. Plaintiffs allege that design defects cause excessive amounts of cobalt and chromium to corrode and wear from the surfaces of the acetabular cup, femoral head and taper sleeve as the metal parts rub against each other. This excessive wear makes the Biomet M2a Magnum Hip system prone to fail, according to the complaint.

Plaintiffs allege that a Biomet Magnum hip recall should have been issued years before McCoy’s surgery, indicating that Biomet received hundreds of reports of failures not long after the implant was launched.

“By the time Biomet sold the M2a Magnum Hip System to Plaintiff, numerous reports had been filed with the FDA reporting an adverse event associated with the M2a Magnum Hip System,” according to the complaint. “Consequently, Biomet was fully aware that the M2a Magnum Hip System was defective and that dozens of patients already had been injured by the defect. Based on this information, Biomet should have recalled the M2a Magnum Hip System before it was sold to Ms. McCoy.”

As early as August 2004, Biomet received a complaint involving a patient who required additional surgery to remove and replace a Biomet M2a Magnum Hip that had become loose only three years after it was implanted. However, according to allegations raised in McCoy’s complaint, Biomet closed its investigation into the matter.

More than 350 additional adverse events have allegedly been reported to the FDA involving problems with the Biomet M2a Magnum Hip System.

McCoy and her husband join a growing number of other plaintiffs throughout the United States who have filed a Biomet Magnum hip lawsuit after experiencing similar problems with the metal-on-metal hip replacement system. 

Concerns about the safety of all metal-on-metal hip replacement systems increased in 2010, after a DePuy ASR hip recall was issued due to higher-than-expected failure rates. More than 90,000 of the recalled implants were sold worldwide before the problems were acknowledged by the manufacturer, and thousands of individuals throughout the United States have already filed a DePuy ASR hip lawsuit after experiencing complications with the implant.

Manufacturers of other metal-on-metal hip replacements also face similar lawsuits over problems with their implants, including the DePuy ASR hip, DePuy Pinnacle hip and Wright Conserve hip.