This report is being amended to reflect changes.Other device used: catalog #00584200602, nexgen zuk precoat tibial component, lot # 62403426.Review of the device history records did not find any deviations or anomalies.This device is used for treatment.A product history search revealed no additional complaints against the related part and lot combinations.A definitive root cause cannot be determined with the information provided.However, the complaint may be revised upon return of product or further information.
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