In a lawsuit, a Michigan patient says that the Biomet Magnum hip implant is defective and dangerous, and that its maker, Biomet, knew of the device’s dangers but marketed it as safe and effective, endangering the health of patients.

The Biomet Magnum hip implant lawsuit was filed by plaintiffs Keith and Renee K., who are residents of Kalamazoo County, Mich. The couple claims that Keith had a Biomet Magnum hip installed during a hip replacement surgery on his right hip.

However, allegedly because of a design defect in the device, two metal components rubbed against one another in such away to cause the hip ball and socket to not fit well together, shed metal components into Keith’s body, and cause such pain and injury that he had to have a revision surgery.

The couple says that Biomet, the makers of the hip system, knew that the metal-on-metal design of the device had a high likelihood of causing such problems in patients, but continued to sell the device anyway. They seek to hold Biomet accountable for Keith’s injury.

They say that Keith had his right hip replaced on or around Dec. 21, 2009, and was fitted with the metal-on-metal Biomet Magnum M2a hip implant.

The couple says that Keith experienced no complications during surgery, and that the hip was replacement was well-placed in his body. However, he states that around Feb. 1, 2017, he told his physician that he was experiencing pain in his right hip and groin, and had noticed a popping and clicking coming from the hip components.

The couple alleges that based on this information, Keith’s surgeon recommended that Keith undergo a revision surgery and have the hip implant replaced with a new one. The couple says that the surgeon recommended that Keith be fitted with a device that had one component made of plastic, unlike the Biomet Magnum hip, which had two metal components rubbing on one another.

In their Biomet Magnum hip implant defect lawsuit, the couple argues that Biomet was able to release the device into the market without enough testing to ensure that it was safe for patients.

Allegedly, the use of metal-on-metal hip replacement implants predates a law that required medical devices like it to be subjected to pre-market approval, the process by which medical devices are rigorously tested before they are granted approval to be sold to the general public.

The Biomet hip lawsuit says that the Biomet Magnum hip implant was approved not through the rigorous testing of the pre-market approval process, but was “grandfathered in” to a faster approval process that allows devices “substantially similar” to those already on the market to be approved with less than the normal amount of clinical testing required under the regular approval process. 

However, the Biomet Magnum hip lawsuit alleges, the device is not substantially similar to other devices on the market. Biomet had only ever claimed that the devices within the hip system were “substantially similar” to devices used in metal-on-plastic hip implants — not metal-on-metal devices. The Biomet lawsuit says that Biomet had not sufficiently established that the devices in the Biomet Magnum hip implant were safe when used in metal-on-metal systems.

The Biomet Magnum Hip Implant Lawsuit is USDC IN/ND Case No. 3:18-cv-00622, in the U.S. District Court for the Northern District of Indiana, South Bend Division.