Biomet Hip Replacements

Orthopedic manufacturer Zimmer bought Biomet for $13.4 billion in 2014. The new company, Zimmer Biomet, became one of the leaders in the hip replacement market in 2016.

Before the acquisition, Indiana-based Biomet Orthopedics was a medical device manufacturer specializing in surgical hip, knee, shoulder and other joint replacement products. However, at the time of Zimmer’s purchase Biomet was facing a number of lawsuits.

The U.S. Food and Drug Administration received hundreds of reports from doctors and patients detailing M2a Magnum-caused complications. Thousands of patients filed lawsuits because of adverse effects of Biomet’s metal-on-metal hip products.

Recently, the U.S. Court Of Appeals for the Eighth Circuit ruled that there was sufficient evidence of “willful and wanton disregard for the rights or safety of another” to support a $2.5 million award to plaintiff Lori Nicholson. Her claim contended that Biomet should have conducted more testing of its M2a Magnum device.

Biomet’s top hip replacement product was the Arcos Modular Femoral Revision System. It included five stems and three body options that could be implanted using three different types of surgical techniques.

The company also sold acetabular components, including products in its G7 Acetabular System and Regenerex RingLoc+ Modular Acetabular System. Biomet also manufactured revision components used in surgery to replace faulty or failed implants from original hip replacement surgery.

The M2a Magnum hip implant products featured problematic metal-on-metal designs that led to complications such as Adverse Reaction to Metal Debris (ARMD). These complications included metallosis, systemic metal ion toxicity, localized tissue damage and pseudotumor formation caused by the release of cobalt and chromium particles into surrounding tissues and the bloodstream.

Biomet’s implants came in a variety of materials such as ceramic, metal and polyethylene plastic. The company claimed that components manufactured with its exclusive E1 Antioxidant Infused Technology had a lower wear rate than other polyethylene products.

In addition to its popular M2a Magnum line of implants, Biomet manufactured other metal-on-metal designs, including the Biomet Stanmore and Exceed ABT. According to Biomet, the company produced the widest range of metal-on-metal hip devices in the industry.

The company first released its M2a line of implant products in 1996, beginning with the M2a RingLoc. From 1999 to 2009, more than 110,000 M2a devices were implanted in patients. The M2a Magnum Large Metal Articulation device, released in 2004, and became a best selling device. 

M2a implants were promoted as being specifically designed for active people. Former Olympian Mary Lou Retton even endorsed the M2a Magnum Large Metal Articulation System after receiving a total hip replacement using this device, along with Biomet’s Taperloc Hip Stem, in 2005. 

The larger head diameter of the M2a Magnum implant allowed for over 160 degrees of motion, ideal for active individuals. However, the increased surface area significantly raised the risk of metal particle generation at the bearing surface, leading to systemic and local tissue complications.

Patients and doctors reported over 450 adverse events involving Magnum implants to the FDA, citing complications such as persistent pain, swelling, implant loosening, premature device failure, fractures, pseudotumors, metallosis and systemic cobalt/chromium toxicity.