UNKNOWN DEPUY INSERT

Description of Event or Problem

PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AND THE TIBIAL TRAY AT BOTH INTERFACES. THE TIBIAL TRAY HAD ALSO SUBSIDED. THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN. UPDATE: (B)(6) 2013- X-RAYS RECEIVED AND ATTACHED TO COMPLAINT. -AM. UPDATE: (B)(6) 2013- MEDICAL RECORDS RECEIVED. -AM. UPDATE (B)(6)2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE OSTEOLYSIS WAS FOUND AS WELL AS YELLOW BLOODY FLUID IN THE JOINT. THE PATIENT'S PATELLA AND INSERT ARE BEING REPORTED.

Additional Manufacturer Narrative

THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT MEDICAL RECORDS AND X-RAYS WERE PROVIDED. REVIEW OF THE SUPPLIED INVESTIGATIONAL INPUTS CONFIRMED OSTEOLYSIS AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE OSTEOLYSIS OR THE LOOSENED FEMORAL AND TIBIAL COMPONENT BASED ON THE PROVIDED INFORMATION. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

Additional Manufacturer Narrative

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