Overview: An Indiana man is suing Biomet after his implant failed, allegedly due to its defective metal-on-metal design. The lawsuit, filed by the national law firm of Parker Waichman LLP, says that because of the harmful characteristics inherent in all-metal hip replacements, the device-known as the m2a Magnum hip system- caused complications and ultimately forced the Plaintiff to undergo surgery in order to remove the implant.
- Parker Waichman LLP filed a lawsuit on behalf of an Indiana who alleges that the Biomet M2a Magnum is defective and prompted the need for early revision surgery
- The M2a Magnum is a type of metal-on-metal hip implant; this class of medical devices is known to have higher failure rates compared to other types of hip replacements
- The FDA recently warned that all-metal hip implants can cause soft tissue reactions due to the release of metal ions
Product: M2a Magnum™ Hip System
Manufacturer: Biomet Orthopaedics
Side Effects & Complications
- High failure rate
- Necrosis (tissue death)
- Increased levels of cobalt and chromium ions
- Pain at the implant, sometimes spreading to the groin and back
- Osteolysis (bone loss)
- Fluid collections/solid masses around the hip joint
Lawsuit Alleges Defective Design Led to Complex Revision Surgery
The lawsuit, which was filed on January 18th in the Marion County Circuit Court, names Biomet, Inc., Biomet Orthopedics, LLC, Biomet U.S. Reconstruction, LLC, LVB Acquisition, Inc., LVB Acquisition Holding LLC and LVB Acquisition Merger Sub, Inc. as Defendants in the case. The lawsuit alleges that the M2a Magnum is defective and caused injures in an Indiana man. According to a press release issued by Parker Waichman LLP, the U.S. Food and Drug Administration (FDA) had already received 100 reports of adverse events associated with the device by the time the Plaintiff received the Biomet M2a Magnum in his left hip; the Defendants, however, never disclosed this information to him, his doctor or the public. After receiving the implant, he suffered from severe pain and loosening at the hip joint. These complications prompted the need for revision surgery to remove the device. In addition to the alleged injuries from implantation, the lawsuit alleges that the revision surgery has placed the Plaintiff at additional risks because this procedure is more complex and risky compared to the initial implantation.
All-Metal Hip Implants Known to Fail Early, Release Metal Particles
Because the Biomet M2a Magnum uses a “monoblock” system, there is no option for an acetabular liner; as a result the metal surfaces can grind against each other with the full weight of the body and release metal ions. As such, it is in a class of medical devices known as metal-on-metal hip implants. Following the thousands of lawsuits and patient complaints about early failure with the devices, the U.S. Food and Drug Administration (FDA) is seeking to tighten regulations on the implants that would require manufacturers to conduct safety tests before selling metal hip implants. The agency recently issued new guidelines for the devices, warning that they can release metal ions and cause soft tissue reactions, pain and swelling when the patient walks or runs. Hip replacement patients who experience such symptoms are advised to speak with their doctor.