Product Liability Lawyer
Norfolk, Newport News, and Roanoke, Virginia
Defective Product Attorney
Zimmer NexGen Knee Implant Recall
Since 2003, medical device manufacturer Zimmer Holdings, Inc. has sold over 150,000 NexGen Flex-Knee Implants. Unfortunately, this medical device has a history riddled with problems, coming under fire for several different defective product issues:
- A record 9% implant failure rate (the industry standard is 1%)
- Reports of device loosening among over 36% of patients
- A frequent need for revision surgery
- Defective surgical instruments released for use with the implant
Zimmer has continued to dodge assertions that the NexGen Knee Implant system is inherently defective, instead choosing to place the blame on surgeons for "incorrectly installing" the implants, and releasing conflicting statements to the public about the reported implant failure rates.
A History of Controversy
The American Academy of Orthopedic Surgeons held a conference in March 2010 during which they presented data concerning the safety of the Zimmer NexGen Flex-Knee Implant system.
The researchers observed 108 different knee replacement surgeries using the Zimmer NexGen CR-Flex Porous Femoral Component. Out of these 108 patients, they discovered that almost 9% of patients needed revision surgery, and 36% of patients showed radiographic loosening of the implants. The physicians stated that, contrary to Zimmer's claims, they did not believe these problems were related to surgeon techniques.
The lead author of the study was orthopedic surgeon Dr. Richard Berger, who has helped design some of Zimmer's past artificial joints and surgical tools. Dr. Berger called the failure rate "unacceptably high," and questioned why the product had been placed on the market without clinical testing.
Components Recalled, But Not the System
Despite widespread criticism from orthopedic surgeons, Zimmer Holdings has still not announced a recall of the Zimmer NexGen Flex-Knee Implant system. However, certain surgical instruments have been recalled, which Zimmer has blamed for several of the system's problems.
One example is the tibial broach impactor that Zimmer created for use with the system. This surgical instrument was recalled after a large number of surgeons reported that the instrument easily broke during surgery, even leaving fragments behind in the bodies of some patients.
Medical device manufacturers are obligated to ensure their products are safe for use, yet Zimmer still continues to market their NexGen Knee Replacement system without clinical trials or adequate testing.
If you have experienced complications with your Zimmer NexGen Knee Implant, you may be entitled to compensation. Contact our product liability lawyers in VA at Kalfus & Nachman today for a free case evaluation. Our firm serves clients in Norfolk, Hampton, Portsmouth, Roanoke, Newport News, and Virginia Beach, Virginia.
