Since the Zimmer NexGen Knee Replacement System was approved by the FDA in 1994, it is estimated that almost half a million people in the U.S. have received Zimmer implants. The NexGen CR-Flex Porous Femoral component in particular, of which more than 150,000 implants have been sold, has been associated with many risks. In addition, many other Zimmer NexGen replacement systems have been linked to a variety of problems.
Patients with these implants frequently experience:
- Extreme Knee Pain
- Loosening of Implant
- Implant Failure
- Limited Range of Motion
- Need for Revision Surgery
Zimmer NexGen knees have a “high-flex” porous femoral component that fuses to the bottom of the thighbone, rather than using cement to keep the knee replacements in place. As a result, many of these implants may result in failure more quickly and frequently than traditional knee implants.
FDA Issues Recall
In September 2010, the U.S. Food and Drug Administration (FDA) issued a class 2 recall for the NexGen Complete Knee Solution MIS (minimally invasive surgery) tibial components, locking screw, and stem extensions. The recall targeted more than 68,000 knee components, following at least 114 reports of complications that caused loosening of the parts and/or the need for additional knee surgery.
Knee Surgeons Link Implant to High Failure Risk
A study presented to the American Association of Surgeons (AAOS) in 2010, revealed that the NexGen CR-Flex Knee Replacement System had an extremely high failure rate. The study of 108 patients, conducted by prominent orthopedic surgeons Dr. Richard Berge and Dr. Craig Della Valle, found that:
- 9 percent of patients experienced knee failure within two years
- 36 percent experienced painful loosening of components
Dr. Berger concluded that the issue was a design problem, rather than surgical error or patient factors. Though initially a Zimmer consultant, he stopped using the devices in 2005. In 2010 Berger expressed to The New York Times that, “I have lost confidence” in regard to Zimmer.
Patients who suffer from the failure and complications of a Zimmer NexGen Knee device may be entitled to financial compensation. Contact our experienced attorneys today for a free consultation. We will listen to your story and help you determine the best course of action for your case.