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Biomet was a large manufacturer of hip replacement products before it was bought by its competitor Zimmer. Several Biomet hip implants helped improve patient’s lives, but one line of products didn’t live up to expectations. Biomet’s metal-on-metal implants cost the company millions of dollars in litigation and compensation costs.

*Please seek the advice of a medical professional before discontinuing the use of this medical device.

Indiana-based Biomet Orthopedics was a medical device manufacturer that specialized in surgical products to replace the hip, knee, shoulder and other joints. Orthopedic manufacturer Zimmer bought Biomet in 2014 for $13.4 billion. The new company, Zimmer Biomet, became one of the leaders in the hip replacement market in 2016.

Before the acquisition, Biomet’s top hip replacement product was the Acros 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. The company’s products had well-documented histories of success, but Biomet was not immune to failures.

The 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.

The U.S. Food and Drug Administration received hundreds of reports of complications from doctors and patients who used the M2a Hip implant line of products. However, the devices were never recalled. Thousands of people filed lawsuits against the manufacturer, and Biomet agreed to settle a large number of cases in 2014. However, 457 lawsuits were still pending against the company in March 2017.

Biomet’s Hip Replacement Products

Biomet manufactured hip replacement devices for all types of hip replacement surgeries. These devices included femoral, acetabular and revision components. Revision components are used in surgery to replace faulty or failed implants from original hip replacement surgery.

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.

Biomet Products, Hip Systems and Components

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 released its lucrative 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. Biomet claimed the M2a design increased long-term performance, allowed for a wider range of motion and decreased dislocation rates.

The M2a line included the following models:

  • 28mm M2a-Taper
  • M2a-Magnum
  • 32mm M2a-Taper
  • M2a-38
  • M2a-Magnum Tri-Spike
  • M2a-RingLoc

The M2a Magnum Large Metal Articulation device was released in the Unites States in 2004 and was one of the company’s bestselling devices. Following the release of this device, all M2a implants were consolidated under the M2a Magnum brand.

The devices were monoblock implants, meaning they were composed of a single component, and each M2a model had slight differences in design to accommodate different patient needs. The M2a Magnum line included several acetabular products composed of a cup (or shell), metal liner and metal ball.

The M2a Magnum Large Metal Articulation System was endorsed by former Olympian Mary Lou Retton, who suffered from hip dysplasia and damage to her hips during her career as a gymnast. Retton received a total hip replacement using this device, along with Biomet’s Taperloc Hip Stem, in 2005.

M2a implants were designed for active people. The larger head diameter had the potential for more than 160 degrees of motion. The downside to the larger heads was that the surface area rubbing against the inside of the cup was larger, which increased surface wear. That meant more metal particles could be released into the blood and surrounding tissues.

More than 450 adverse events involving Magnum implants were reported to the FDA by patients and doctors. Complications included pain, swelling, premature device failure and fractures that required revision surgery

History of Biomet Hip Replacement Lawsuits

A number of people developed pain and disability as a result of the M2a Magnum. Thousands filed lawsuits against Biomet over the design.

In October 2012, a federal judicial panel centralized Biomet M2a Magnum hip implant lawsuits in the Northern District of Indiana. Judge Robert L. Miller Jr. presided over the litigation known as Multidistrict Litigation No. 2391.

Multidistrict litigation is used to consolidate similar cases and improve court efficiency. More than 2,663 people filed lawsuits in the MDL.

  • Patricia Gill, from New York, received an M2a Magnum implant in 2005 in her right hip. In a lawsuit, she claimed that friction and wear between the metal components released chromium particles into her blood and tissues, causing severe pain and inflammation. She received revision surgery to replace the implant. She sought compensation for medical expenses, pain and suffering, lost wages and punitive damages.
  • Christina Kirk, an Ohio woman, received an M2a Magnum hip implant when she underwent a total right hip replacement in 2007. She claimed that she suffered severe physical injuries caused by the release of metal ions into her body. She filed a lawsuit in federal court in May 2013.

In January 2014, Biomet agreed to settle all M2a Magnum cases for a combined $56 million. That amounted to a base award of $200,000 for each plaintiff.

Biomet M2a $53 million case settlement stat

Terms of M2a Magnum Hip Settlement

The Biomet hip settlement was available for cases in the federal MDL as well as state courts. To participate, injured consumers had to file their claims in state or federal court by April 15, 2014.

People who received a Biomet M2a 38 or M2a Magnum hip replacement system as part of an initial hip replacement that was revised more than 180 days after it was implanted were eligible for a base award of $200,000.

However, that award was subject to the following discounts:

  • $10,000 if the implant was revised more than five years but less than eight year, after initial implantation
  • $37,500 if the hip replacement was revised more than eight years but less than ten years after initial implantation
  • $10,000 if the implant was initially implanted after August 1, 2010, but before July 1, 2011
  • $37,500 if the hip replacement was initially implanted after July 1, 2011, but before January 27, 2012.
In addition, the following types of cases received reduced awards:

  • Cases that were revised more than 10 years after initial implantation received $20,000
  • Cases involving a hip replacement system implanted after January 27, 2012 received $20,000
  • Cases barred by statutes of limitation received $20,000
  • Claimants who received Biomet metal-on-polyethylene devices or metal-on-metal hip replacements other than the M2a 38 and the M2a Magnum (M2a Taper, RingLoc, or ReCap) received $20,000
  • Claimants who first received any type of hip replacement as part of a revision procedure or who had their implant revised within six months of initial implantation received a payment of $20,000
  • Deceased plaintiffs who received a Biomet metal-on-metal hip and who underwent revision but who died for reasons unrelated to alleged complications received $20,000.

Biomet said it would only fund the settlement if 90 percent of the qualifying cases accepted the settlement. Plaintiffs had to submit information to the court by June 13, 2014. In its 2015 annual report, Zimmer Biomet estimated that it would take $33.4 million to resolve pending claims.

Author

Chris Elkins is a writer and researcher for Drugwatch.com. He’s worked for various newspapers and has writing experience in sports, health communication and public relations fields.

View Sources
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  2. Collins, S. (2016, April 8). Zimmer Biomet’s Competition in the Hip Implant Market. Retrieved from http://marketrealist.com/2016/04/zimmer-biomets-competition-hip-implant-market/
  3. Fay Cortez, M. (2014, April 24). Zimmer to Buy Biomet for $13.4 Billion Adding Orthopedics. Retrieved from https://www.bloomberg.com/news/articles/2014-04-24/zimmer-agrees-to-buy-biomet-for-13-35-billion-including-debt
  4. Greene, K. (2014, February 3). Biomet to Pay $56M to Settle Hip Replacement MDL. Retrieved from https://www.law360.com/articles/506687/biomet-to-pay-56m-to-settle-hip-replacement-mdl
  5. Huff, T.W. & Sculco, T.P. (2007). Notes from the acetabular side: Mono to modular options. Orthopedics, 30(9). Retrieved from http://www.healio.com/orthopedics/hip/journals/ortho/%7B21af5696-06c3-4618-bca9-03e2dbf0daef%7D/notes-from-the-acetabular-side-mono-to-modular-options
  6. Pritchett, J.W. (n.d.). Metallosis of the resurfaced hip. Retrieved October 25, 2012, from http://www.pritchettorthopedics.com/articles/pritchett_metallosis_of_the_hip.pdf
  7. U.S. Food and Drug Administration (FDA). (2008, September 25). MAUDE Adverse Event Report: Biomet Inc. M2a 38MM Cup Prosthesis, Hip. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1206663
  8. U.S. Food and Drug Administration (FDA). (2011, September, 12).MAUDE adverse event report: Biomet Orthopedics Inc. Biomet M2a-Magnum total hip implants Biomet total hip implants. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2655985&DEVICE_SEQUENCE_NO=2
  9. United State District Court Northern District of Indiana. (n.d.). MDL 2391. Retrieved from http://www.innd.uscourts.gov/mdl-2391
  10. United State District Court Northern District of Indiana. (n.d.). Settlement Agreement Between Biomet, Inc. and Plaintiffs Executive Committee for In Re: Biomet M2a Magnum Hip Implant Products Liability Litigation, MDL No. 2391. Retrieved from http://www.innd.uscourts.gov/sites/innd/files/Biomet%20Settlement%20Agreement.pdf
  11. United States Judicial Panel on Multidistrict Litigation. (2012, October 2). In Re: Biomet M2a Magnum Hip Implant Products Liability Litigation Transfer Order. Retrieved from http://www.innd.uscourts.gov/sites/innd/files/MDL%202391%20transfer%20ord.pdf
  12. United States Judicial Panel on Multidistrict Litigation. (2017, March 15). MDL Statistics Report – Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2017.pdf
  13. Zimmer Biomet. (n.d.). 2015 Annual Report. Retrieved from http://files.shareholder.com/downloads/ZMH/4075333924x0x882366/03D970B5-3039-43D3-A2C5-67266EAA19B6/2015_Annual_Report_FINAL.pdf
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