National law firm, Parker Waichman LLP, just filed another lawsuit over alleged Biomet M2a Magnum™ injuries. This time, the lawsuit was filed on behalf of a Missouri man who was implanted with the metal-on-metal hip implant.
The lawsuit alleges that the allegedly defective metal-on-metal design of the Biomet M2a Magnum™ caused the man to suffer from painful complications including elevated levels of metal ions—chromium and cobalt, specifically—and that he had to undergo painful and complex revision surgery to remove the defective hip device and be implanted with a different device.
The lawsuit was filed on November 26th in the U.S. District for the Western District of Missouri, Central Division (Civil Case No. 2:12-cv-4297). Biomet, Inc. and Biomet Orthopedics, LLC have been named as defendants in this case.
According to the complaint, the man was implanted with the Biomet M2a Magnum™ hip system in both hips; his implants failed, causing him severe pain, elevated chromium and cobalt levels, and significant economic loss. The complications ultimately forced him to have to undergo a revision surgery to remove the device. The lawsuit also alleges that the procedure itself put the man at additional risk, because revision surgeries are typically more complex than the initial implantation surgery.
A total hip replacement consists of an acetabular component, a cup or shell that acts as the hip socket, interacting with a femoral component. The lawsuit points out that, while some hip replacements offer a plastic liner to be used in conjunction with the acetabular cup, the M2a Magnum™ hip implant lacks this option because it uses a so-called “monoblock” system. Because of this, the lawsuit alleges, the Biomet M2a Magnum™ forces metal to rub against metal with the full weight of the body, which releases metal ions into the bloodstream.
The lawsuit also alleges that the defendants knew about the risk of premature failure associated with the M2a Magnum™, yet never conveyed sufficient warnings to the plaintiff or the public in order to meet their own financial interests. According to the lawsuit, the U.S. Food and Drug Administration (FDA) had received 100 adverse event reports linked to the M2a Magnum™ at the time the plaintiff received his implants.
Metal-on-metal hip implants have been linked to high rates of implant failure and early revision. In March, The Lancet published a study showing that all-metal hip implants fail at a rate of six percent in five years, compared to the two percent seen in plastic or ceramic devices. These findings prompted the authors to call for an end to their use.
The FDA also addressed risks associated with metal-on-metal hip implants and asked 21 manufacturers to conduct post-market safety studies on the devices to assess whether they release dangerous amounts of metal ions into the body. This summer, an FDA advisory panel met to discuss the pros and cons of the devices. At the conclusion of the three-day meeting, the experts advised that metal hip patients undergo yearly physicals, imaging scans, and possible blood screening for metal ions in order to detect complications. Some panelists questioned whether or not metal-on-metal hip replacements should be used at all in the future.