About Zimmer Biomet
Zimmer Biomet Holdings is a medical device company that designs, develops, markets, and manufactures orthopedic reconstructive, spinal, and trauma devices, dental implants, and orthopedic surgery supplies. Zimmer operates in over 25 countries around the world and sells its products in over 100 countries.
Zimmer Biomet offers reconstructive devices that help patients to restore function lost from disease or trauma. Zimmer supplies and is best known for making implants for knees, hips, elbows, and shoulders. Zimmer is one of the world’s largest producers of knee replacement devices and controls around 25 percent of the knee replacement market.
Both Zimmer and Biomet, separately and as a combined company, have faced thousands of lawsuits for injuries caused by their hip and knee replacement devices. Some of these lawsuits have resulted in large settlements, however many may still be pending in court systems.
Zimmer Biomet History
Zimmer Orthopaedics was founded in 1927 by Justin Zimmer in Warsaw, Indiana with other manufacturing facilities in Dover, Ohio and Statesville, North Carolina. The company acquired a competitor Biomet, in 2015, making it one of the largest global orthopedics device companies with estimated annual revenue of about $8 billion.
The offer for Biomet was made in April of 2014, and was said to cost $13.4 billion, however EU antitrust regulators objected over concerns the combination would limit competition in certain markets. The company was cleared, and the acquisition allowed to proceed for completion in June of 2015.
The company has since acquired additional orthopedics and sports medicine companies including:
- ETEX Holdings
- Ortho Transmission
- Cayenne Medical
- LDR Holding Corporation
- CD Diagnostics
- Clinical Graphics B.V.
A major concern for Zimmer Biomet, involving its joint replacement products is that research findings have suggested that cobalt and chromium metal fragments and ions released from implant devices may affect nearby tissues of patients. These metal particles may result in cellular changes that cause cancer in 20 percent of patients with all metal implants but more commonly may result in joint tissue loss or dissolution, bone fracture and other complications.
Many patients have required revision surgeries and other added medical expense from Zimmer Biomet products. As a result of this and other problems experienced by patients, many lawsuits have been filed against Zimmer Biomet for hip and knee replacement device injuries.
Zimmer Biomet Products
Zimmer Biomet has operations around the globe and offers both medical devices, along with surgical products and management solutions.
Management solutions include:
- Patient engagement and care management platforms through smart devices
- Data solutions and clinical insights
- Robotic systems for Knee, Neurosurgery, Surgical Assist Arm
- Ambulatory Surgery Center coordination
Zimmer Biomet also offers medical devices in the areas of:
- Foot and Ankle
- Limb Salvage
- Sports Medicine
- Bone Healing
Zimmer Biomet Hip Replacement Complications
Zimmer has had a number of problems related to their hip replacements. Many patients that had received the implants reported severe reactions to metal debris from the components. Zimmer has since been held accountable for patients experiencing serious health conditions such as metallosis, osteolysis, and osteonecrosis.
Infections have occurred in about 1 percent of the demographic. Although rare, a severe infection from a hip implant can eventually lead to an amputation. If the infection is caught within a month of surgery, the surgery site is re-opened, cleaned, and sometimes the implant must be removed and re-implanted.
Zimmer Biomet Knee Replacement Complications
Zimmer Holdings has a number of knee replacement products on the market. While popular, the knee replacements are known to have caused problems in patients. Quality issues and vulnerability to infections are some of the common issues affecting those with Zimmer knee replacements.
Other problems from Zimmer knee replacements include:
- Fracturing or loosening of knee replacement parts
- Instability or dislocation of the joint
- Misalignment or breakdown of replacement components
- Nerve damage
- Fractured bones
- Pain and swelling in joint
Loosening is among the most common issues from a faulty knee replacement. This happens when the components of a knee replacement become separated from the bone. Soft tissues might begin to grow in between the implant components and bones, which causes instability and pain for the patient. Loosening of a knee replacement is common over time but a faulty knee replacement may begin to show problems in less than a year.
Zimmer Durom Cup Recall and Lawsuit
One of the most notable hip implant recalls involved the Durom Cup, manufactured by Zimmer Holdings.
In 2007, nationally recognized surgeon, Lawrence Dorr reported problems with the Durom Cup in several of his patients. Dr. Dorr claimed that the hip replacements would fail only a few months after surgery, resulting in serious pain and risk to patients and most commonly requiring corrective revision surgery to remove and replace a device that he stated was poorly constructed.
The Durom Cup continued to be used until 2008 and was then recalled by Zimmer. The company told the U.S. Food and Drug Administration (FDA) that instructions for surgical technique and use were inadequate but admitted no wrong in the quality of construction of the devices. Zimmer Holdings temporarily advised orthopedic surgeons to avoid the use of the Durom Cup until additional training was provided.
The device was restored to market sales in 2009, however hundreds of people have filed Durom Cup lawsuits due to serious injuries and Zimmer chose in 2010 to discontinue the device. In 2010, Zimmer set up a $47.5 million fund, which was expanded after a Los Angeles man won his Durom cup lawsuit and in March 2016, Zimmer proposed to settle remaining Durom cup hip replacement lawsuits for a total of $314 million.
Zimmer Biomet Lawsuits
Zimmer Biomet has faced multiple lawsuits including:
- Zimmer Durom Cup
- Zimmer M/L Taper Hip implant
- Zimmer Versys Femoral Head
- Zimmer Kinective Technology devices
- Biomet M2a Magnum Hip system
- Zimmer NexGen Knee devices
- Zimmer Persona Knee devices
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.