UNKNOWN DEPUY PATELLA

Description of Event or Problem

PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENT AT THE CEMENT/IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION. 03/07/2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS INDICATE A PRE-REVISION X-RAY TAKEN OF THE RIGHT KNEE REVEALED OSTEOLYSIS SURROUNDING THE TIBIAL STEM.

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

IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH BY LOT WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED FOR REVIEW. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4). PATIENT MEDICAL RECORDS WERE RECEIVED AND REVIEWED. REVIEW OF THE MEDICAL RECORDS CONFIRMED DEVICE LOOSENING. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE ROOT CAUSE OF THE DEVICE LOOSENING WITH THE INFORMATION AVAILABLE. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.