ZIMMER NexGen KNEE
New Jersey Zimmer NexGen Knee Implant Lawyer
The NexGen CR-Flex and LPS-Flex Fixed Bearing Knee, designed and manufactured by Zimmer Holdings, Inc., is a so-called “high flexion” knee replacement that affords recipients a greater range of motion for activities that require deep bending. Introduced in 2003, the NexGen knee is available as a cemented or cementless device, the difference being that the former is attached to a patient’s thigh bone via acrylic bone cement, while the latter has a porous coating that allows bone ingrowth to secure the device without the use of an adhesive. Zimmer has sold approximately 150,000 of the devices since 2003, but in the last few years, data has emerged that suggest the cementless NexGen CR-Flex Porous Femoral component is failing prematurely in a high percentage of recipients, including failure caused by aseptic loosening.
In 2006 Dr. Richard Berger, a prominent orthopedic surgeon from the Rush University Medical Center in Chicago and consultant to Zimmer who helped train other surgeons in minimally invasive surgical techniques, noted loosening of the NextGen knee in some patients who received the NexGen CR-Flex or LPS-Flex Porous Femoral component. He reported this to Zimmer on more than one occasion and the company responded that it was Berger’s surgical technique, not the device, that was the problem. This is a surprising conclusion to have reached, according to Berger, who said, “[s]uddenly, I went from someone who was their master teacher to someone who didn’t know what he was doing.”
Berger subsequently ceased using the device and in an effort to avoid a publicity battle with Zimmer, recruited the help of a colleague at Rush, Dr. Craig J. Della Valle, who had similarly encountered problems with the NexGen device in some of his patients. Together, the two doctors completed a study of implanted NexGen knees (presented at the 2010 conference of the American Academy of Orthopaedic Surgeons) and found that of the 120 cementless CR-Flex Porous Femoral components used, 36 percent were loose and nearly 8.5 percent had failed completely and been revised. Berger called the failure rates “horrific” and he and Della Valle concluded that, [t]his component is still commercially available but should not be used for any patient.” They also underscored the need for premarket testing of new designs. The cementless NexGen CR-Flex Porous Femoral component was approved for sales by the FDA without undergoing clinical trials, which are typically required for medical devices.
Zimmer, which has since cut its consulting ties with Berger, responded to the unfavorable findings by pointing to the NexGen’s high rate of successful implantation in Australia. While this is true, no reason for the device’s high failure rate in this country has yet been reported. Berger stated that he has lost confidence in Zimmer.
With a lawsuit against Zimmer, we may be able to help you obtain compensation for your pain and suffering and other damages. To learn more about a potential Zimmer NexGen CR-Flex or LPS-Flex Knee lawsuit, you should contact us immediately as the statutes of limitations restrict the time frame in which you may be able to pursue your claims. If you believe that you or a loved one has been seriously injured due to these products, and you are interested in learning more about how we can help, please contact us today.
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