87 JDI DEPUY INTERNATIONAL, LTD.

THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. 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 INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

PT WAS REVISED TO ADDRESS DISLOCATION.

ON (B) (6) 2010, INITIAL SURGERY WAS DONE FOR FEMORAL NECK FRACTURE. ON (B) (6) 2010, WHEN THE PATIENT MOVED TO ANOTHER BED, DISLOCATION OF THE IMPLANTS FROM ACETABULUM WAS NOTED. THE DOCTOR TRIED TO DO MANUAL REDUCTION, THE HEAD WAS REMOVED FROM THE NECK OF THE STEM. ON (B) (6) 2010, REVISION SURGERY WAS DONE TO REPLACE THE IMPLANTS.

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