Richard A. Berger, MD, a Chicago orthopedic surgeon who had been helping Zimmer for many years to design devices, said one the company’s NexGen CR-Fle, was failing prematurely. The CR-Flex model of the original NexGen knee allows orthopedic surgeons like Dr. Berger to refrain from using adhesives.
Dr. Berger co-authored a study showing premature failures of the knee, but Zimmer told him the problem lay with his surgery, not the product, and did not renew his consultancy contract last year.
The FDA approved the NexGen CR-Flex, an update of the NextGen model, without any testing in patients. When another orthopedic surgeon, Lawrence Dorr, MD, of Los Angeles, complained about the device, the FDA briefly halted sales of the device and began investigating it. But when Zimmer provided data from 12 surgical centers showing that the hip’s efficacy, the agency closed its investigation.
While heart implant industry has a voluntary system of review by outside panels when such disputes arise, no such mechanism exists for disputes over products from U.S. orthopedic device makers. “There is no way of knowing who is right because we don’t have the data,” said Kevin J. Bozic, MD, professor of orthopedic surgery at the University of California, San Francisco.
Read the New York Times report on orthopedic devices.
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