The Zimmer NexGen Knee Implant Controversy Article

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The Zimmer NexGen Knee Implant Controversy

Zimmer Holdings, Inc. – a medical device manufacturer based in Indiana – specializes in developing high-end joint replacement prosthetics, such as knee and hip implants. In 2003, the company released the NexGen CR-Flex Fixed Bearing Knee, a new knee-replacement implant designed to provide an improved range of motion for patients.

Author: Sara Goldstein

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Two different version of the NexGen CR-Flex were released:
• A cemented version that bonds using an adhesive
• An uncemented version that bonds through natural bone ingrowth

Both knee models were designed to last around 15 years. Unfortunately, the uncemented implant has endured widespread criticism from the orthopedic community for higher-than average failure rates, frequent loosening of the device, and the release of defective surgical instruments designed to be used with the implants.

Dr. Richard Berger and the American Association of Orthopedic Surgeons

Criticism surrounding this defective medical product began with Dr. Richard Berger, an orthopedic surgeon who used to be a high-profile consultant with Zimmer, helping them train hundreds of surgeons in minimally-invasive techniques. Dr. Berger’s relationship with Zimmer Holdings began to degenerate once he voiced his concerns about the CR-Flex Porous Femoral component, which was not properly fusing in several of his patients.

When Berger reported this to Zimmer, the company proceeded to blame his own surgical techniques instead of the device. In response, Berger ceased using the NexGen knee implant, and in 2007 joined forces with a co-worker to complete a study on the faulty CR-Flex component.

The two surgeons presented the results of their research at a March 2010 convention of the American Association of Orthopedic Surgeons. After evaluating 108 patients with uncemented NexGen knee implants, they found:

• 39 patients (36%) encountered loosening of the device
• 9 patients (8.3%) needed revision surgery

The average implant failure rate in the industry hovers at around 1%. The NexGen knee implant’s almost 9% failure rate is unprecedented, and led the doctors to conclude that although the implant is still commercially available, “it should not be used for any patient.” Both doctors also stressed the need for clinical studies of the new designs, which were FDA-approved despite a lack of pre-market testing.

No Recall Announced Yet
Despite the controversy surrounding Zimmer’s NexGen Knee Replacement System, the faulty device remains on the market and in use by patients nationwide. The only recall that has taken place is a recall of certain surgical instruments Zimmer is blaming for most of the implant’s complications, such as:

• The tibial broach impactor
• The locking screw
• Stem extensions

Zimmer blames these tools for at least 114 of the FDA-reported instances of implant loosening. A number of surgeons reported that the tibial broach impactors broke very easily during surgery, sometimes leaving metal fragments behind in patients’ bodies.
If you have suffered complications related to your Zimmer NexGen knee implant, you may be entitled to compensation. Please visit the website of the experienced defective product attorneys at Kalfus & Nachman today for more information.

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Kalfus & Nachman’s personal injury attorneys legally represent clients who have been involved in auto accidents, medical malpractice, nursing home negligence, and defective product cases. Contact us for an initial case evaluation at no cost.

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