UNIDENTIFIED KNEE IMPLANT

Description of Event or Problem

PATIENT WAS REVISED TO ADDRESS LOOSENING OF UNKNOWN KNEE COMPONENT AT THE CEMENT/IMPLANT INTERFACE. THE CEMENT MANUFACTURER IS UNKNOWN AT THE ORIGINAL TIME OF IMPLANTATION. THE PAIN CAN BE ATTRIBUTED TO THE LOOSENING OF THE UNKNOWN COMPONENTS.

Additional Manufacturer Narrative

THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEW AND/OR SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

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. WHILE WE HAVE PART NUMBERS, IT IS CODED AS UNKNOWN BECAUSE IT IS UNCLEAR OF WHICH COMPONENT WAS LOOSE. A FOLLOW-UP WAS CONDUCTED, BUT THE SALES REP COULD NOT CONFIRM WHAT WAS LOOSE.