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Hazard alert - NexGen Complete Knee Solution MIS stemmed tibial component
Hazard alert - faulty threads potentially preventing installation of drop-down stem extension or stem plug.
Consumers and health professionals are advised that Zimmer, in consultation with the TGA, has issued a hazard alert regarding its NexGen Complete Knee Solution MIS total knee procedure stemmed tibial component (various sizes).
The affected medical device is used in knee replacements and comprises a tibial baseplate with a threaded hole into which a drop-down stem extension or stem plug can be screwed.
A manufacturing defect left faulty threads in some devices manufactured before 3 April 2014, potentially preventing proper installation of the drop-down stem extension or stem plug.
In some cases this could potentially lead to loosening or failure of parts of the implant. Read more here.
Last modified: Wed, 06 Aug 2014 12:57:24 BST