July 9, 2014 — Zimmer has issued a hazard alert for the NexGen Complete Knee Solution in Australia to address problems that could lead to premature loosening and failure of the implant.
Over 1,000 lawsuits involving components of the NexGen have been filed against Zimmer in federal court.
The Australian Therapeutic Goods Administration (TGA) issued the alert after finding that the tibial baseplate was manufactured with a defective threads in a hole where surgeons can screw in a drop-down stem extension or a stem plug.
The problem was found on devices manufactured before April 3, 2014. Zimmer is concerned that it could prevent proper installation of the drop-down stem extension, which could lead to loosening.
Safety risks linked to the Zimmer NexGen recall:
- Additional bone loss if the MIS tibial component is cemented in place before the defect is discovered, requiring additional surgery to remove and replace the implant.
- Early revision surgery due to loosening and/or infection if the tibial component is implanted without a drop-down extension.
- If the stem extension does not fully seat due to thread misalignment, the articular surface may not fully lock and disassociation may occur.
Zimmer has already recalled the NexGen Complete Knee Solution MIS tibial components in 2010. At least 114 adverse event reports involving loosening and revision surgery were reported at the time of the recall. Over 68,000 products were distributed worldwide.
Do I have a Zimmer NexGen Knee Implant Lawsuit?
The Schmidt Firm, PLLC is currently accepting Zimmer NexGen induced injury cases in all 50 states. If you or somebody you know has been injured by a defective knee replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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