87HRY DEPUY (IRELAND)

THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAM. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE REPORTED PRODUCT LOT CODES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

PT REVISED FOR LOOSE FEMORAL AND TIBIAL COMPONENTS.

PT HAS COMPLAINED OF PAIN OVER A LONG PERIOD OF TIME. ON OPENING THE KNEE, BLACK METAL DEBRIS WAS NOTED IN THE SYNOVIUM ALONG WITH SCRATCHES IN THE DIRECTION OF MOVEMENT ON THE DISTAL CONDYLES OF THE FEMORAL COMPONENT.

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.