Zimmer NexGen Knee Replacement Linked to New Type of Failure

Rochester, MNPatients who received the Zimmer NexGen Knee Replacement could be at increased risk of failure of the implant, according to researchers. Zimmer reportedly faces NexGen lawsuits, alleging patients were harmed by defective Zimmer knee replacement devices, requiring revision surgery to remove the faulty implant.

A study, presented in February 2012 to a meeting of the American Academy of Orthopaedic Surgeons (and reported by The Wall Street Journal; 2/6/12), suggests that the Zimmer NexGen is associated with a risk of isolated debonding, which occurs when the knee implant loosens from the cement. Researchers at the Mayo Clinic studied more than 1,350 total knee replacements from 2000 through 2011 that used the Zimmer NexGen knee replacement with one certain tibial component. Of the 3.9 percent of knee replacements that failed, 50 percent failed because the implant came loose from the surrounding bone. And, of those 50 percent, 80 percent of the failures were caused by isolated debonding.

Researchers noted that they had not seen problems with isolated debonding in other implants used at the Mayo Clinic.

In 2010, a surgeon who once trained doctors in using Zimmer joints spoke out about problems with the Zimmer knee. According to The New York Times (6/19/12), Dr. Richard A. Berger made more than $8 million in a 10-year period in his work with Zimmer. After Dr. Berger went public with a story illustrating what he said was a high premature failure rate, Zimmer argued that the problem was not with the joint but with Dr. Berger's technique.

The Zimmer NexGen knee was approved by the US Food and Drug Administration in 1994. The NexGen CR-Flex, which is the implant Dr. Berger spoke out about, was designed to provide a wider range of motion than the typical NexGen device by relying on the bone to fuse with the implant, rather than using cement. The implant was supposed to last about 15 years, but Dr. Berger found that some patients experienced loosening of their knee implant after surgery.

Lawsuits have been filed against Zimmer, alleging patients required revision surgery—where the implanted device is replaced by a new device—after their Zimmer NexGen device failed. The lawsuits seek compensatory damages for pain and suffering, emotional distress, and economic loss. Plaintiffs allege the various Zimmer NexGen Knee implant components are defective and caused serious injury.