The national law firm, Parker Waichman LLP just filed a lawsuit on behalf of a woman implanted with a Biomet M2a Magnum™ hip implant in both of her hips. The lawsuit alleges that the metal-on-metal hip replacement device is defective, and caused recurring dislocations. This forced the woman to undergo several revision surgeries.
The lawsuit alleges that the Biomet M2a Magnum™ caused serious injuries to the woman who originally underwent a bilateral total hip replacement. The suit was filed on November 7th in the U.S. District Court for the Middle District of Florida, Orlando Division (Case 6:12-cv-01677-CEH-GJK). Biomet, Inc. and Biomet Orthopedics, LLC have been named as defendants.
The woman received the Biomet M2a Magnum™ in both her left and right hips, and both failed. Because of this, she suffered from severe pain, instability, and recurrent dislocations. The complaint indicates that these complications led to multiple revision surgeries conducted to correct the problem.
Also, according to the complaint, the U.S. Food and Drug Administration (FDA) had already received numerous adverse event reports associated with the implant by the time it was implanted in this woman. Because of this, according to allegations in the lawsuit, Biomet was fully aware that its Biomet M2a Magnum™ device was defective yet continued to the flawed device to not only the plaintiff but to other consumers, as well. The lawsuit is holding the defendants liable for consequences suffered by the plaintiff, which include economic damages, severe and potentially permanent injuries, pain, suffering, and emotional distress.
The Biomet M2a Magnum™ is a metal-on-metal hip implant that the lawsuit alleges was not properly tested by Biomet. Unlike other types of hip replacement devices, the M2a Magnum™ does not have the option of an acetabular cup liner, which, allegedly, causes metal to rub against metal with the full weight and pressure of the human body.
The lawsuit claims that, as a result of this defect, excessive amounts of cobalt and chromium ions are released from the device into the patient’s body. These defects manifest with symptoms of pain, looseness, dislocation, and squeaking and popping sounds from the site of the implant. The lawsuit also alleged that the body’s reaction to the metal particles resulted in fluid accumulation and damage to soft tissues and bone.
Metal-on-metal hip implants, as a class, have become the subject of safety concerns in the orthopedic community. Since these devices were approved using the fast-tracked 510(k) approval route, clinical testing was not needed before the devices were sold to the public.
Now, studies reveal that metal hip replacements tend to fail more often than other implants. In fact, according to a study published earlier this year in the Lancet, metal-on-metal hip implants failed at a rate of six percent in five years, as opposed to the approximate two percent seen with alternative implants. Last month, the journal published another study showing “unacceptably high” rates of failure for patients who undergo hip resurfacing, a newer type of metal-on-metal hip replacement that attempts to preserve more bone.