Biomet Hip Replacements
Biomet was a large manufacturer of hip replacement products before its competitor Zimmer purchased it. While some Biomet products had well-documented records of success, the metal-on-metal M2a Magnum hip implant products were associated with complications including metal poisoning or metallosis.
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Biomet Acquisition and Legal Issues
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 Hip Replacement Products
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.
Its M2a Magnum hip implant products contained problematic metal-on-metal designs. The M2a Magnum caused a variety of complications, including metallosis, which is metal poisoning that occurs when metal particles are released into the blood from the artificial joint.
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.
- Primary Femoral Components
- Answer Hip System, Balance Femoral Component, Bi-Metric Porous Primary Femoral Component, Bi-Metric Interlok Femoral Component, Bio-Groove HA Hip System, Biomet Hip Fracture Femoral Component, Bio-Moore II Hip System, Generation 4 Polished Hips System, Integral Centralizer Femoral Component, Integral Reduced Proximal Profile Femoral Component, Rx 90 Smooth Primary Femoral Component Stanmore Hip System, Mallory-Head Interlok Femoral Component, Taperloc Hip System
- Revision Femoral Components
- Bi-Metric Head/Neck Replacements,Reach Revision System, Bi-Metric Long Stems, Rx 90 Revision System, Integral 180 Femoral Component, Mallory-Head 1pc Calcar Femoral Component, PLR Proximal Loading Revision Stem, Mallory-Head Modular Calcar Revision System, Reach Modular Revision System, Arcos Modular Femoral Revision System
- Primary Acetabular Components
- Bio-Clad Polyethylene Acetabular Component, C2a – Taper Acetabular System, Full Hemisphere Solid Acetabular Component M2a – Ringloc Liner, M2a – Taper Acetabular Hip System, M2a – 38 Metal-on-Metal Acetabular Hip System, QSAC Quadrant Sparing Acetabular Component, Ranawat/Burstein Polyethylene Acetabular Component, RingLoc Acetabular Liners, RingLoc Acetabular Series, RingLoc Bi-Polar Articulating Hip System, Rx 90 Low Profile Acetabular Component, Rx 90 Polyethylene Acetabular Component, Tri-Spike Acetabular Component, Universal Acetabular Component, Vision Acetabular Component, Mallory-Head Radial Acetabular Shell, M2a-Magnum Large Metal Articulation
- Revision Acetabular Components
- Biomet Tri-Polar Acetabular System, Freedom Constrained Liner, Healey Flanged Revision Acetabular Component, Par 5 Acetabular Reconstruction System, Recovery Protrusio Cage, Mallory-Head +5 Acetabular Component, Regenerex Acetabular Reconstruction System
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.
M2a Magnum Hip Implants
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.
- 28mm M2a-Taper
- M2a-Magnum
- 32mm M2a-Taper
- M2a-38
- M2a-Magnum Tri-Spike
- M2a-RingLoc
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 had the potential for more than 160 degrees of motion. The larger surface area,however, also meant more metal particles could be released into the blood and surrounding tissues.
Patients and doctors reported more than 450 adverse events involving Magnum implants to the FDA. Complications included pain, swelling, premature device failure and fractures that required revision surgery.
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