87HRY DEPUTY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS

PATIENT WAS REVISED TO ADDRESS CHRONIC PAIN.

THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE 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 ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.