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By: Staff Writers | Published: March 31st, 2010
Orthopedic surgeons have released a new report that highlights the risk of problems with Zimmer NextGen knee replacement systems, which have been found to have a high rate of failures and revisions.
At the American Academy of Orthopaedic Surgeons annual conference in New Orleans earlier this month, data was presented by a group of knee surgeons at Rush University Medical Center in Chicago, who said that design problems with the Zimmer NexGen knee replacement has caused an abnormally high rate of loosening that often requires additional revision surgery.
The orthopedic surgeons looked at the two year results of 108 knee replacement surgeries involving the Zimmer NexGen CR-Flex Porous Femoral knee replacement system, which uses a component that attaches to the bottom of the thigh bone without traditional cement to glue it in place. The researchers found that nearly 9% required revision surgery and that 36% showed signs of the replacement knee loosening, concluding that the Zimmer NexGen knee problems were linked to the design of the implant, and were not related to the surgeon, the surgical approach or the type of patient receiving the knee implant.
According to a report in The Wall Street Journal, surgeons have previously brought these issues to Zimmer’s attention and called for the company to remove their NexGen knee replacement product from the market. However, Zimmer Holdings, Inc. has not been responsive to their request and issued a statement standing behind the safety of the NexGen CR-Flex Porous component after the data was presented.
Zimmer has previously faced criticism over the design of their Durom Cup hip implants, which are used during hip replacement surgery and have been associated with a number of complications. In July 2008, a temporary Zimmer Durom Cup recall was issued after the company acknowledged that some doctors experienced high failure rates with the artificial hip implant.
Prior to the recall of that hip implant, the device maker dismissed reports of problems with the Durom Cup, leading a prominent Los Angeles orthopedic surgeon, Dr. Larry Dorr, to present data to members of the American Association of Hip and Knee Surgeons in April 2008 about the higher-than-expected rate of revisions with the Durom Cup. Zimmer then conducted an investigation and found that some surgeons were experiencing hip failure rates as high as 5.7%, leading them to pull the artificial hip from the market until further warnings and instructions on special surgical techniques needed to implant the Durom Cup. The company now faces a number of lawsuits from hip replacement patients who experienced problems with the Zimmer Durom cup, and have reportedly reached settlements in some of the cases.
Since the data was presented earlier this month about the Zimmer knee replacement problems, some product liability lawyers have begun investigation potential Zimmer NexGen replacement knee lawsuits for individuals who have experienced complications, such as loosening of the knee implant or revision surgery.