NexGen CR-Flex Knee Device Criticized by Former Zimmer Consultant

Dr. Richard A. Berger, former orthopedic consultant for Zimmer Holdings, has had a public falling out with the medical device company. For years, Berger was a star consultant who’d been paid more than $8 million for his expertise concerning artificial hips and knee devices.
Berger’s relationship with Zimmer was severed after Dr. Berger complained that the NexGen CR-Flex knee was failing at an unacceptable rate. Zimmer officials blamed Berger’s surgical technique for the failure rate. That’s when Zimmer decided to terminate its relationship with the surgeon.
According to Berger, the NexGen CR-Flex artificial knee was designed to provide more flexibility and range of motion than the previous model, the NexGen. Berger told the NY Times that he had given 125 patients the new NexGen CR-Flex since 2005. The new knee was supposed to last 15 years. However, by early 2006, x-rays were showing that the device was loose and had not fused properly to the bone. Berger’s patients were reporting pain while walking and complained to him about the knee implant. Berger reported the complaints to Zimmer officials who dismissed Berger’s claims. The NexGen CR-Flex uncemented knee had no test data because the FDA had not required testing prior to selling the new knee.
Since at the time no other surgeons complained about the knee, Zimmer executives told Berger that the problem had to concern his surgical technique.
By 2007, Berger had stopped using the Zimmer knee device and had decided to perform his own study of the NexGen CR-Flex with another surgeon. The surgeons found that the knee failed in 9% of the cases and that the knee showed signs of looseness in about half of all Zimmer knee patients.
Zimmer continues to dispute Berger’s claims as well as his test results. This leaves patients with a problem-who do they trust?