Zimmer Biomet is a medical device manufacturer formed when Zimmer Holdings acquired competitor, Biomet. The combined research, development and manufacturing capabilities have made Zimmer Biomet the second largest orthopedics device manufacturer in the world.
Zimmer Biomet manufactures a range of orthopedics products, including some of the most popular joint replacement devices. Though most people who undergo hip replacement, partial hip replacement or hip resurfacing experience greater mobility and functionality, some experience serious complications. Thousands of people have filed Biomet hip replacement lawsuits due to injuries caused by the Biomet M2a-Magnum hip implants.
What is Zimmer Biomet?
Zimmer Biomet is a giant in the joint replacement and surgical products medical device arena. They manufacture products dealing primarily with the musculoskeletal system of the human body and can be used with surgical and non-surgical techniques.
Zimmer was established in Indiana in 1927 by Justin Zimmer. In April 2014, Zimmer agreed to purchase Biomet, a competing company located in the same area. Zimmer specialized in reconstructive orthopaedic implants and trauma products. Prior to the acquisition of Biomet, Zimmer had acquired a number of medical products companies including Centerpulse, InCentive Capital, ORTHOsoft, Medizen Technik, Knee Creations and ETEX Holdings.
Biomet, a medical device company, was established in Indiana in 1977 as a competitor to Zimmer. The company specialized in hip & knee products, extremity products, surgical products, bone cement & accessories. Biomet had formed a significant part of its business through acquisitions of companies including Merck KGaA, Innovations, Kirschner Medical, W. Lorenz Surgical, Arrow Surgical Technologies, Electro-Biology, and Orthopaedic Equipment Company.
Zimmer Biomet remains headquartered in Warsaw, Indiana. The company has expanded a number of times through additional acquisitions including Ortho Transmission, Cayenne Medical, LDR Holding, CD Diagnostics, and Clinical Graphics. The company and its subsidiaries have thousands of employees, currently distributes products to approximately 90 countries and has estimated annual revenue of about $8 billion.
Hip Products
Following are the famous and commonly used hip products:
- Active Articulation™ Dual Mobility Hip System
- Arcos Modular Femoral Revision System
- G7™ Acetabular System
- ReCap Femoral Resurfacing System
- Regenerex Porous Titanium Construct
- Signature™ Hip Technology Personalized Patient Care
- Taperloc Complete Hip Stem
- Regenerex RingLoc + Modular Acetabular System
- E1 Antioxidant Infused Technology
- Echo™ Hip System
- M2a-Magnum™ Large Metal Articulation
- Biolox delta Ceramic Femoral Heads
Types of Hip Products
Zimmer Biomet hip devices offer a number of hip solutions for joint replacement, joint preservation, partial hip replacement, fracture, revision surgery and bone growth solutions.
The Zimmer Biomet hip products fall into the following categories:
- Femoral components to replace/repair the ball portion of the femur
- Acetabular components to repair/replace the socket portion of the pelvic bone
- Revision components which are post-surgically used products for replacing the faulty and failed components
- Adjunct products such as fixatives, cements, anchors, tissue grafts and other products
Metal-on-metal Hip Implants
Many types of materials have been used for implants with mixed results. Metal-on-metal and metal-on-polyethylene were very common with similar results. Nowadays, Biomet manufactures metal-on-metal implants using Cobalt (Co) and Chromium (Cr) metals. The famous products of this line include M2a Magnum hip implant, Stanmore and Exceed ABT.
The metal-on-metal hip implants fall into following two categories:
1. Metal-on-metal total hip replacement systems
This system includes both femoral and acetabular components. The total hip joint is replaced by a metallic prostheses. An acetabular capsule is prepared on the pelvis and the complementary femoral component is properly placed in the shaft of the femur. These two surfaces articulate to produce a wide range of motions similar to natural hip joint. An example is M2a Magnum hip implant.
2. Metal-on-metal resurfacing hip systems
Metal-on-metal resurfacing hip systems are preferred sometimes because they preserve the bone on the femoral side. In case of a faulty or failed implant, the reserved bone can be used for a total hip replacement.
M2a Magnum Hip Implants
Hip replacements can help a person regain mobility and live pain-free, but they can also have the opposite effect and turn a tolerable health issue into something devastating. Much of the risk is based on the type of hip replacement a patient and his or her doctor choose.
Many metal-on-metal replacements have caused pain and injury for users. Information published in the British Medical Journal showed metal-on-metal options appear to be increasingly less effective as a solution for hip replacement. Additional research from the US Food and Drug Administration reported more than 12,000 issues were reported with metal-on-metal devices in 2011, which was nearly double the number reported with other devices.
Zimmer Biomet offers seven different metal-on-metal implants. The prototype metal-on-metal hip implant was first introduced in May 1996 under the trade name, “M2a-RingLoc”. It was followed the M2a-Taper, ReCap-Femoral and M2a-Magnum.
The Biomet M2a Magnum Hip System is one that has come under intense scrutiny for causing a number of health issues. It is marketed for its enhanced durability, but research has shown this type of replacement actually carries a great deal of risk for failure.
The harmful effects of M2a Hip Implant system are diverse and include:
Pain
Pain is a common side effect, particularly in the younger patients. Almost 20% of patients complain of post-operative pain at the site of implantation. It is often associated with signs of inflammation, redness, tenderness, swelling and warmth.
Metallosis
The deposition of metal debris resulting in increased plasma concentration of metals, results from shaving off metals by friction. In a recent study, it was demonstrated that almost all the patients suffer from severe metallosis after 10 year of metal-on-metal implant.
Loosing and Dislocation
Surfaces of the implant can wear down and loosen leading to complications and joint dislocation.
Fractures
The bone can weaken and fracture while attempting to hold the implant in place. This complication is more common in post-menopausal females.
Revision Surgery After Device Failure
There are a variety of problems that can lead to revision surgery. Mechanical failure, infection and recurrent hip dislocation can all prompt a doctor to consider a revision surgery. Often the revision surgery is more dangerous than the initial surgery and can further damage the area of the implant.
Biomet Hip Settlements
More than 2,800 Biomet Hip lawsuits were filed over the Biomet M2a-Magnum devices. Federal cases for Biomet Hip Implant injuries were consolidated in multidistrict litigation (MDL) in 2012. Though the cases were set to begin in 2014 in the U.S. District Court for the Northern District of Indiana, the company offered $56 million to settle over 1,140 cases for up to $200,000 each.
Biomet has faced charges with the Securities and Exchange Commission (SEC) regarding violations of the Foreign Corrupt Practices Act. The company was found to have bribed doctors in Argentina, Brazil and China to use its devices paid $22.9 million in 2012 to settle the charges, however the company faced additional inquiries which delayed a merger with Zimmer Holdings who also faced a large number of hip device lawsuits as well.
While litigation was pending, Zimmer acquired Biomet, becoming the second largest orthopedics manufacturer in the world, Zimmer Biomet. Some reports indicate that there may still be about 190 cases pending for Biomet hip injuries.
which had been intended to take place in 2014. If the merger goes through, the Zimmer/Biomet Company will be the second largest orthopedics manufacturer in the world but Zimmer faces a large number of hip device injuries as well.
Though Biomet has offered settlements to thousands of plaintiffs, many lawsuits have not been settled and more are expected. Not all potential lawsuits will qualify for a settlement as each case is different and evaluated individually.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
Sources
- No superiority of cemented metal-on-metal vs metal-on-polyethylene THA at 5-year follow-up, Orthopedics (2009)
- One-year prospective comparative study of three large-diameter metal-on-metal total hip prostheses: serum metal ion levels and clinical outcomes, Orthopedics Traumatol Surg Res (2012)
- Biomet Hip Lawsuit News: Plaintiffs’ Counsel Endorses Appointment of Special Master in Biomet Hip Replacement Litigation (10/2013)
- Concerns about Metal-on-Metal Hip Implants, US Food and Drug Administration 01/2013)
- Settlement Agreement Between Biomet, Inc. and Plaintiffs Executive Committee for In Re: Biomet M2a Magnum Hip Implant Products Liability Litigation, U.S. Courts MDL No. 2391
- Biomet to Pay $56M to Settle Hip Replacement MDL, Law360 (02/2014)
