NexGen Knee Implant Revision Surgery - Doctors Call for a Recall

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Zimmer, a manufacturer of medical implant devices, has recently come under fire for problems associated with its NexGen CR-Flex Porous knee replacement system, primarily premature failure. Some are even calling for a a comprehensive recall of Zimmer NexGen. The CR-Flex system is designed to adhere to the patient’s bone without the use of adhesive cement. The device fuses to the femur, or in some cases the tibia, bone through the use of cobalt-chromium-molybdenum alloy and porous fiber metal that mimics human bone.

Concerns over the knee implant device date to 2006, when one of Zimmer’s own surgeon consultants, Dr. Richard Berger, raised concerns to the company over the device’s premature failure. At the time, Zimmer rejected Dr. Berger’s claims as unfounded, blaming the surgeon’s technique, and not the device, for the failures. More recently, however, Dr. Berger has publicly backed his concerns with a study that demonstrate the implant device’s problems. Specifically, Dr. Berger indicates that beginning in 2005, he used the Zimmer NexGen CR-Flex device with 125 patients. The device is projected to last 15 years, but Dr. Berger stated that it had already begun failing in a number of patients in just one year. In the actual study that Dr. Berger conducted with Dr. Craig Della Valle, the CR-Flex device failed completely within two years in 9.3% of patients, and exhibited signs of loosening in approximately 36% of patients. Over half of the 100 patients in the study experienced knee pain and other problems from loosening of the implant. Overall, the study reported that patients with the implants commonly experience:

Device Failure
Need for Revision Surgery
Loosening of Implant Components
Knee Pain
Compensation Pain and Problems

Since the release of that study, Zimmer has come under some scrutiny for its handling of the safety concerns. In a letter dated July 29, 2010, Senator Charles Grassley, in his capacity as member of the Senate Committee on Finance, requested information from Zimmer regarding: the procedures that Zimmer has in place to respond to safety allegations and concerns raised by its consultants; which Zimmer consultants have in fact raised safety concerns about Zimmer products; how those concerns were dealt with; and whether Zimmer collects data on the performance of its devices.

In September of 2010, the FDA issued a Class 2 recall of certain components of the NexGen Complete Knee Solution MIS. The device is often used for patients with severe pain and disability that have resulted from certain types of arthritis, trauma, collage disorders, and deformities. The recall comes after Zimmer had received complaints of the implant device loosening, which in turn required a second, revision, surgery for the affected patients.

Tags: Product Liability, Knee Replacement, Zimmer, Medical Devices