CEMENTRALIZER 13.0

Additional Manufacturer Narrative

IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem

LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, SWELLING, INFLAMMATION AND INFECTION. UPDATE REC'D (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION PROVIDED. A CORRECT DOI AND DOR WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT HAD A POLY LINER IMPLANTED SO THE OTHER IMPLANTS BESIDES THE HEAD AND LINER CANNOT BE EXCLUDED AS THE CAUSE THE PAIN. ALL OTHER IMPLANTS ARE BEING ADDED TO THE COMPLAINT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

Additional Manufacturer Narrative

THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE CC6LS4000 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.