Biomet Hip Lawsuit Filed Over Defective M2A Metal-on-Metal Implant

Design problems with metal-on-metal hip implants have been linked to high failure rates for years, according to lawsuit filed by man who suffered metal blood poisoning.

An Arizona couple has filed a product liability lawsuit over the allegedly defective design of Biomet metal-on-metal hip implants, which they say led to the need for the husband to undergo revision surgery after he developed metal blood poisoning and the implant failed.

The complaint (PDF) was filed by Timothy and Barbara Sprecke in the U.S. District Court for the District of Arizona on December 12, naming Biomet, Inc., Biomet Orthopedics LLC, Biomet Manufacturing, LLC., Biomet US Reconstruction, LLC and Zimmer Biomet Holdings, Inc. as defendants.

According to the Biomet hip lawsuit, the company’s M2a metal-on-metal implant was unreasonably dangerous and defective, and the manufacturer failed to disclose information about the risk of failure associated with the implant, which has been used in total hip replacement procedures, featuring a metal femoral head and a metal acetabular cup, which is intended to provide enhanced durability and reduce wear compared to traditional materials.

Biomet’s M2a metal-on-metal hip implant received U.S. Food and Drug Administration (FDA) clearance in 2004 through the 510(k) premarket notification process, which is a regulatory pathway that allows devices to enter the market based on its similarity to existing products without the need for extensive premarket clinical testing.

However, metal-on-metal hip implants like the Biomet M2a have faced scrutiny in recent years due to high failure rates and complications, which can occur as metal debris is released when the parts rub against each other, leading to tissue damage and a risk of the implant loosening.

According to the complaint, Sprecker was implanted with a Biomet M2a metal-on-metal right hip in December 2001, and ultimately required replacement surgery in December 2022 to remove the failed implant.

Sprecker claims he also experienced metal ion disease and a range of complications caused by metal toxicity in his body from the Biomet hip implant. The lawsuit states he exhibited significantly elevated chromium and cobalt levels, chronic inflammation, adverse local tissue reactions and systemic health issues linked to the toxic effects of metal exposure.

However, the lawsuit states that Biomet was aware of numerous reports of Biomet M2a hips failing by the time the device was implanted, indicating that the manufacturer knew or should have known that the metal-on-metal hip design was unreasonably dangerous.

The lawsuit indicates Biomet made false representations about the safety of the implant, claiming that it was superior to other, safer implants on the market.

“Relying on Biomet’s representations, Plaintiff’s orthopedic surgeon decided to use the M2a MoM Hip System,” the lawsuit states. “But for Biomet’s misrepresentations, plaintiff’s orthopedic doctor would not have used the M2a MoM Hip System for Plaintiff’s hip replacement surgery.”

The complaint asserts claims of strict product liability, including manufacturing and design defects, failure to warn and negligence. Additionally, his wife has filed a claim for loss of consortium.

Over the last 20 years, a number of hip replacement recalls and problems have been associated with metal-on-metal designs. In addition, some concerns have been raised about the development of tumors and a potential risk of cancer that may be associated with the design.

Similar allegations were raised in nearly 12,000 DePuy ASR hip lawsuits filed against Johnson & Johnson, after their metal-on-metal implant was recalled in August 2010. Following several bellwether trials, the manufacturer ultimately agreed to pay more than $2.4 billion to settle the DePuy ASR litigation.

Other metal-on-metal hip replacement lawsuits have also been filed and resolved over similar designs, including the DePuy Pinnacle, Biomet Magnum and others.