87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS Report # 1626225
PT WAS REVISED TO ADDRESS TIBIAL LOOSENING. POLY WEAR WAS DISCOVERED INTRAOPERATIVELY. (B) (6).
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS Report # 1626225
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS Report # 1618331
PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING AT CEMENT/IMPLANT INTERFACE. TYPE OF CEMENT UNK.
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS Report # 1618331
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE FOR THE FEMORAL COMPONENT DID NOT SHOW ANY OTHER REPORTS AGAINST THE LOT CODE. THE MANUFACTURER OF THE CEMENT PRODUCT WAS REPORTED AS UNK. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS Report # 1615223
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 INFORMATION. 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS Report # 1615223
PATIENT WAS REVISED TO ADDRESS FEMORAL AND TIBIAL LOOSENING.
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS Report # 1581346
PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL.
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS Report # 1581346
THE PRODUCTS WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE MANUFACTURING LOTS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE LOOSENING. PROVIDED INFORMATION STATED THE PRODUCTS WERE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR OF CONTRIBUTING TO THE EVENT. 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.