The reported event could be confirmed, since evaluation of x-rays provided does show the surface coating of the tibial tray has detached.Medical affairs was asked to review the available information and x-ray provided.According to their review, "the x-rays indeed show a medial malleolar fracture.The slightly displaced medial malleolar fracture fragment ripped of the surface coating from the tibial tray.So in this case the bond between the coating and the bone proved to be stronger than the bond between the tibial tray and its coating.Mechanically, after reduction and fixation of the fracture the medial malleolus and the tibial tray will not be bonded together and will stay a weaker spot.Also, there is a bone cyst medially to the base of the inbone stem.Over time micromotion and metallosis may occur." based on investigation, the root cause was attributed to a patient factors related issue.The event was caused by a fracture in the medial malleolus after a bond had been created with the bone and tibial tray coating.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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