87HRS DEPUY ACE S.A. 'R.L.

PATIENT WAS REVISED BECAUSE, THE RADIAL HEAD COLLAPSED POST-OP, EXPOSING ONE OF THE SCREWS, WHICH ERODED THE CAPITULUM, CREATING PAIN AND NECESSITATING REMOVAL.

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

PT WAS REVISED TO ADDRESS FRACTURE OF THE PLATE.

EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO REVIEW OF THE INFO PROVIDED, AS THE LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. PROVIDED INFO STATES THE PLATE WAS PUT INTO THE PT'S WRIST IN 2009. AT THREE MONTHS POST-OP THE PT PICKED UP HIS GRANDDAUGHTER AND FELT PAIN IN HIS WRIST. X-RAYS WERE TAKEN AND FOUND THE PLATE BROKEN. IN THE INDICATION SECTION OF THE SURGICAL TECHNIQUE IT STATES THESE IMPLANTS ARE INTENDED AS A GUIDE TO NORMAL HEALING AND ARE NOT INTENDED TO REPLACE NORMAL BODY STRUCTURE OR BEAR THE WEIGHT OF THE BODY IN THE PRESENCE OF INCOMPLETE BONE HEALING. DELAYED UNIONS OR NONUNIONS IN THE PRESENCE OF LOAD BEARING OR WEIGHT BEARING MIGHT EVENTUALLY CAUSE THE IMPLANT TO BREAK DUE TO METAL FATIGUE. ALL METAL SURGICAL IMPLANTS ARE SUBJECTED TO REPEATED STRESS IN USE, WHICH CAN RESULT IN METAL FATIGUE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.