Zimmer NexGen CR-Flex Knee Replacement Lawyers
Personal Injury Lawyers - Representing People Nationwide
The Zimmer NexGen CR-Flex knee replacement system has been used with more than 150,000 patients since 2003. It is generally recommended for use with first-time knee replacement patients. Unlike many of the alternative systems which use surgical cement to ensure that the implant remains in place, the Zimmer NexGen CR-Flex knee implant is not attached with cement. As a result, the device has experienced a higher-than-normal failure rate, requiring patients to undergo painful revision procedures.
FDA policy allows the agency to approve medical devices without clinical trials if the device is deemed to be highly similar to existing products on the market. Zimmer was able to take advantage of this loophole in order to push the NexGen CR-Flex knee replacement system through the approval process without conducting clinical trials. Had Zimmer been required to perform clinical trials on the device, the design defect associated with its cementless attachment system may have been identified sooner. There is growing evidence linking this defective medical device to problems including:
- Loosening of the implant
- High failure rate resulting in the need for revision surgery
Mounting Evidence against Zimmer NexGen CR-Flex Knee Replacement Systems
Orthopedic Surgeons Dr. Richard Berger and Dr. Craig Della Valle recently conducted a study on the Zimmer NexGen CR-Flex knee replacement system. They presented their findings to the American Association of Orthopedic Surgeons in March 2010. Their data indicated that approximately 9% of patients receiving the Zimmer NexGen CR-Flex knee replacement system experienced implant failure within two years, requiring a revision procedure. Typically, knee replacements are designed to last approximately 15 years.
The study also found that 36% of patients experienced implant loosening which was accompanied by serious pain. Additionally, the Australian National Joint Replacement Registry has reported 120 instances of revision procedures associated with this defective medical device since 2004. Despite this substantial body of evidence, the Zimmer NexGen CR-Flex knee replacement system remains on the market. Instead of initiating a recall, Zimmer has claimed that surgeon error is responsible for the problems associated with their product.
Zimmer NexGen CR-Flex Knee Replacement Lawsuits
Zimmer is currently facing product liability lawsuits associated with this defective medical device. If you have suffered pain, implant loosening, or implant failure after receiving a Zimmer NexGen CR-Flex Knee replacement system, you may be entitled to receive compensation for your damages. These are highly complex claims and require the assistance of an experienced product liability attorney who can successfully battle the high-powered legal teams employed by medical device manufacturers.
This is not the only knee replacement system that has faced lawsuits associated with product defects. In recent years, many product liability lawsuits have also been filed in association with the Stryker knee replacement system and the Oxinium knee implant system.
Please contact a qualified defective medical device attorney today to find out the best way to proceed with your claim.