Recently, there have been several recalls and thousands of lawsuits directed at Zimmer Biomet for failures related to their NexGen Flex line of knee replacement devices. The Food and Drug Administration (FDA) has issued several product recalls. The company has issued several voluntary recalls as well after several studies revealed flaws in the product, which may cause premature loosening, requiring expensive and risky corrective surgery.
Have you experienced problems or complications with your knee replacement? If you or a loved one shows any of the following signs or symptoms and has a Zimmer knee replacement, they may have received a defective product. Please consult with a doctor and then contact the Peterson Law Firm for a free case evaluation.
If you have suffered from a defective Zimmer NexGen Flex knee replacement, you may be entitled to compensation. Call us today at 1-844-855-8445 for a free case evaluation.
These problems have been traced to a design flaw in the product. Zimmer has faced thousands of lawsuits in response to this issue, and the FDA issued a recall in 2010. If you are experiencing pain, loose joints, stiffness or any of the listed symptoms related to a Zimmer NexGen Knee Replacement, you might require expensive and painful revision surgery.
In some cases, it may take several surgeries to repair the problem with high associated risks and costs. This will also result in extended recovery time, lost mobility, costing you time at work or with your family.
The primary line of products that are affected are the NexGen Flex line, first introduced in 2001. Zimmer has been producing knee replacement implants since the 1960’s, and the NexGen Complete Knee Solution System was introduced in 1995. However, the majority of problems are associated with the NexGen Flex line.
Zimmer Biomet, founded in 1927, is the world’s largest manufacturer of artificial knee replacement devices. The company originally began selling aluminum splints, but expanded into high-tech artificial joints by the 1980’s. Their 2013 sales were approximately $4.62 billion, and they employ about 9,000 globally.
The Next Generation Complete Knee Solution System was introduced by Zimmer in 1995 and sold over 3 million units. The company attempted to improve upon this model in 2001 with the NexGen Lateral Posterior Stabilizing (LPS) Flex-Fixed Bearing Knee. This was dubbed a “High Flex” knee replacement intended to offer a greater range of motion than the older model. This line of joint replacements was able to skip the extensive testing normally required for medical devices, by claiming it was identical to its non-High Flex knee replacements except for small changes to allow for greater range of motion.
The NexGen LPS-Flex was the first device in the line and it was also the first that exhibited problems. A study published in 2007 found 57 percent of these knee replacements had become loose within three years, requiring revision surgery. Similar problems were found with the NexGen CR-Flex in a study published in 2010. Additional products were found to have problems associated with loosening, not binding to the bone properly, and not offering the degree of flexion promised.
The FDA issued two Class 2 recalls in 2010 of Zimmer NexGen Flex products, which affect tens of thousands of products. The company is now facing over one thousand lawsuits and issued a voluntary recall in 2014 of nearly 40,000 NexGen Knee models due to defective screws.
The NexGen Flex line of knee replacements was largely marketed to a younger, more active demographic. They were sold on the surgery based on the idea that they would be able to squat, kneel and sit on their heels more easily than older designs.
Where most joint replacements last 15 to 20 years before requiring revision surgery, the NexGen Flex line had dismal failure rates within the first two years, with a majority of patients experiencing extreme pain and discomfort.
A combination of poor design, lack of testing and bad quality control, all driven by a desire to rush a product to market to maximize profits, demonstrates negligent and irresponsible behavior on the part of Zimmer. Their decisions have caused millions to suffer excruciating pain, and undergo unnecessary, expensive and debilitating surgery.
If you or a family member has experienced pain and suffering due to a faulty Zimmer knee replacement device, contact The Peterson Law Firm, experienced defective medical device lawyers, today for a free case evaluation. We will fight to get you the justice you deserve.
At Peterson & Associates, P.C., we offer 100% FREE consultations and we only get paid if we obtain a recovery on your behalf. Fill out our case evaluation form today for a free consultation.