The manufacturer became aware of adverse events from the national joint replacement registry of the (b)(6) orthopedic association.The report is associated with the remotion system, within that report, 3 post-operative complications/ revisions were reported, which occurred in 2008, 2009 and 2013.The reason for revision were loosening (1 case), implant breakage wrist plate (1 case) and infection (1 case).A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 3 complaints were initiated retrospectively.This product inquiry addresses revision surgery due to infection.
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