Two prominent Chicago orthopaedic surgeons are calling for the recall of Zimmer’s NexGen CR-Flex Knee replacement devices. The porous femoral component (that is, the part of the replacement that covers the head of the femur, the bone that goes from the pelvis to the knee) is associated with a high rate of failure. The two Chicago surgeons calling for the Zimmer recall, Richard Berger and Craig Della Valle from Rush University Medical Center, have observed after two years’ of use that 36% of the implants were loose, and 9.3% were revised or set to be revised because of looseness and associated pain.
The doctors stated that “[t]his component is still commercially available but should not be used for any patient.” They also questioned the fact that the product was released for sale to the public without clinical testing. Dr. Berger described the failure rate as “horrific.”
Dr. Berger has contacted Zimmer, but observes that they have not been receptive to his concerns.
The exact reason for the failure of the device is not yet known. The CR-Flex Knee uses a porous, non-cement femoral component. In other brands, cementless femoral components tend to work fine. However, Zimmer’s product is another story.
Zimmer issued a statement, essentially claiming that Doctors Berger and Valle simply implanted their devices incorrectly, and noting that the Australian National Joint Replacement Registry reveals a high success rate. But, Zimmer has good reason to be concerned—the NexGen products made up 2% of the company’s $1.76 billion sales in 2009, with over 150,000 sales since they hit the market in 2003.
If you or a loved one has a Zimmer NexGen knee implant that causes pain, requires revision or replacement, or causes other complications, please contact us at 1.800.553.8082 or fill out our on-line evaluation form.
