87 JWH DEPUY ORTHOPAEDICS, INC.

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

PT WAS REVISED TO ADDRESS FEMORAL AND TIBIAL LOOSENING. POLY WEAR AND OSTEOLYSIS WERE DISCOVERED INTRAOPERATIVELY.

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

PT WAS REVISED TO ADDRESS FEMORAL AND TIBIAL LOOSENING. POLY WEAR AND OSTEOLYSIS WERE DISCOVERED INTRAOPERATIVELY.

PT WAS REVISED TO ADDRESS FEMORAL AND TIBIAL LOOSENING. POLY WEAR AND OSTEOLYSIS WERE DISCOVERED INTRAOPERATIVELY.

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

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

PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE PATELLA.

THE PRODUCTS WERE NOT RETURNED FOR EXAMINATION. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF PRODUCTS TO EXAMINE AND INSUFFICIENT PRODUCT INFORMATION. IT WAS NOTED THE PRODUCTS WERE IMPLANTED FOR APPROXIMATELY FOURTEEN YEARS PRIOR TO REVISION. BASED ON THE INVESTIGATION FINDINGS, 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.

PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING. POLY WEAR AND OSTEOLYSIS WERE DISCOVERED INTRAOPERATIVELY.