Knee Replacement Component is Defective. A lawsuit filed in Illinois federal court claims that the alleged faulty design of Zimmer Holdings Inc.’s NexGen CR-Flex Porous Femoral component caused the plaintiff’s knee replacement to fail prematurely. The NexGen CR-Flex Porous Femoral component has been the subject of controversy recently, and in 2010, two prominent surgeons published a study in which they asserted that the devices “should not be used for any patient.”
Unlike traditional knee implants, the NexGen CR-Flex Porous Femoral component is made of a porous fiber metal and a cobalt-chromium-molybdenum alloy and is not attached using cement. The component relies on the bone naturally fusing with the implant. It is designed for use in highly active patients who wish to continue high level activities after their knee replacement, and who desire more range of motion than can be achieved via traditional procedures.
The plaintiff in the Illinois lawsuit received a knee replacement with the NexGen CR-Flex Porous Femoral component in November 2007. According to his complaint, he was forced to undergo a knee replacement revision in 2010 after it was determined that his implant had loosened.
plaintiff underwent his revision surgery
The same year the plaintiff underwent his revision surgery, Dr. Richard Berger (at one time a Zimmer consultant) presented a study at an American Academy of Orthopaedic Surgeons conference that indicated that 36 percent of the Zimmer NexGen CR-Flex Porous Femoral component patients examined after two years showed signs of the replacement knee loosening. The study, which was coauthored by Dr. Craig Della Valle, involved 108 patients, and found that nearly 9 percent had to undergo revision surgery within two years of receiving their implant. It was Drs. Berger and Della Valle who advocated that surgeons avoid using the component.
The New York Times has previously reported that when Dr. Berger informed Zimmer about the problems he had experienced, company officials suggested his technique was to blame for the problems. Zimmer claimed that no other surgeons had made similar complaints. Even after he and Dr. Della Valle presented their study, Zimmer wasn’t convinced by their findings, citing positive results in a large database of orthopedic patients in Australia.
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