A paper to be presented at this week’s American Academy of Orthopaedic Surgeons (AAOS) Congress is suggestive of a hitherto unidentified problem with one of Zimmer’s NexGen Knee components. The news is sure to draw attention following the recent publicity surrounding medical device regulation and problems with all-metal hips. According to an item released on nasdaq.com; “The study, conducted by researchers at the Mayo Clinic in Rochester, Minn., is scheduled to be presented Thursday at a meeting of the American Academy of Orthopaedic Surgeons. Researchers looked at 1,373 total knee replacements performed at the center between 2000 and 2011 using a Zimmer NexGen knee with a specific type of tibial component. According to the abstract, 3.9% of the knees failed for various reasons.”
Apparently 50% of the failures were related to loosening, with 80% of those failures resulting from debonding, where the implant separates from the cement, a condition not seen in this centre with other implants.
Zimmer sought to pour water on the flames by stating; “We have spoken to high-volume users of the system, and they haven’t reported any similar events,” said Garry Clark, a Zimmer spokesman. He said the component in question represents 1.2% of Zimmer’s tibial sales.
Source: Nasdaq.com, Dow Jones newswire
published: February 8, 2012 in: Clinical Studies/Trials, Congresses and Meetings, Knee, Zimmer