UNKNOWN DEPUY PATELLA

Additional Manufacturer Narrative

THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFORMATION REQUIRED IN SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT SUPPLIED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT 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 PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

Description of Event or Problem

USER FACILITY MEDWATCH REPORT STATES: THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009. IT IS ASSERTED THAT HE EXPERIENCED UNRELIEVED PAIN SINCE SURGERY. ON (B)(6) 2011 THE PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE REPLACEMENT FOR ASEPTIC LOOSENING OF THE RIGHT TOTAL KNEE. THE OPERATIVE REPORT IDENTIFIED THE PATELLA TO BE LOOSE.

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.