UNK INSERT

Description of Event or Problem

REASON FOR REVISION: PAIN AND POSSIBLE LOOSENING.

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.

Additional Manufacturer Narrative

EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. HOWEVER, THE INITIAL REPORTING INDICATES THAT THE SURGEON DOES NOT FIND THE DEPUY PRODUCT TO BE THE SOURCE OF PAIN OR LOOSENING. THE PATIENT WAS IMPLANTED (B)(6) 1997 AND REVISED ON (B)(6) 2013. IT IS NOT LIKELY THE DEVICE CONTRIBUTED TO THE PATIENTS REPORTED INFECTION 15 YEARS AFTER IMPLANTATION. REVIEW OF PROVIDED PATIENT X-RAY FINDS NOTHING OUTWARD TO SUGGEST ROOT CAUSE. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.