Biomet hip implants include the metal-on-metal M2a Magnum Hip Replacement System, which has been named in hundreds of product liability lawsuits. In 2014, the company agreed to settle many of the claims involving the device for a total of $56 million.
The Biomet M2a line of metal-on-metal hips was brought to market in 1996, and included the following models:
In 2004, Biomet introduced the M2a Magnum Large Metal Articulation device, and consolidated all of the M2a line under the M2a Magnum brand. The M2a Magnum Large Metal Articulation device soon became the best selling Biomet hip implant.
M2a Magnum Biomet hip replacements are designed for active people, and the company promised that the devices would last longer and provide a greater range of motion compared to other hip products. However, according to Biomet hip lawsuits, the large diameter head of the M2a Magnum hip increases surface wear. This purportedly releases metal particles into the blood and surrounding tissue.
Hundreds of people have allegedly experienced pain, swelling, premature device failure and fracture due to the design of the Biomet M2a Magnum hip. It has also been alleged that the toxic chromium and cobalt debris shed from the implants can cause tissue necrosis (death), pseudotumors formation groin pain, swelling, and loosening of the prosthesis leading to dislocation or fracture.
In January 2013, the FDA warned that metal-on- metal hips appeared to be more likely to fail prematurely compared to alternative designs. The agency now advises patients fitted with these types of implants to undergo metal ion blood testing if they experience pain, swelling, or other symptoms that could be indicative of implant failure.
The Biomet M2a Magnum line was approved via the U.S. Food & Drug Administration’s 510 (k) protocols. This process allows device manufacturers to avoid performing human clinical trials if they can show that a device is “substantially equivalent in design” to another product already approved by the agency. In 2011, the Institute of Medicine (IOM) concluded that the 510(k) process was flawed and called for its elimination. Read More
In February 2014, Biomet agreed to settle hundreds of Magnum M2a hip lawsuits pending in a multidistrict litigation underway in U.S. District, Northern District of Indiana. Court records indicated that around 950 such claims were pending in the proceeding.
Cases eligible for the Biomet hip settlement program included those filed before April 14, 2014. Under the terms of the accord, plaintiffs who received one of the affected Biomet hip replacements as part of an initial surgery that was rectified more than 180 days after it was implanted will be entitled to a base award of $200,000. Read More
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