Zimmer is currently facing about 1,000 product liability lawsuits involving components of the NexGen knee replacement.
The product is designed with a tibial baseplate that has a threaded hole into which a drop-down stem extension or stem plug can be screwed.
Unfortunately, a manufacturing defect left faulty threads in some devices manufactured before April 3, 2014. This could prevent proper installation of the drop-down stem extension. This could potentially lead to loosening or failure of the knee implant.
Health issues linked to the problem include:
- Additional bone loss if the implant is cemented in place before the issue is discovered, requiring the implant to be removed and replaced.
- Early revision surgery due to loosening and/or infection.
- Thread misalignment may prevent the articular surface from fully locking, resulting in dislocation.
The issue affects 44 devices that were implanted between May 2010 and April 2011.
In 2010, Zimmer issued a Class II recall for the Zimmer NexGen Complete Knee Solution MIS tibial components, including the locking screw and stem extensions. At the time, over 68,000 products were sold worldwide and the company had 114 adverse event reports involving loosening of the device. Patients needed additional surgery to remove and replace the implant.
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