UNKNOWN DEPUY CENTER-PEG PATELLA

Description of Event or Problem

PT WAS REVISED TO ADDRESS FEMORAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. THE MFR OF THE CEMENT USED IN THE PRIMARY SURGERY IS UNKNOWN. OSTEOLYSIS WAS ALSO REPORTED.

Additional Manufacturer Narrative

THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFO. IT WAS NOTED THE PRODUCT WAS IMPLANTED FOR APPROX FIFTEEN YEARS PRIOR TO REVISION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.