UNKNOWN DEPUY TIBIAL INSERT
Received Jun 22, 2012 · Event occurred Jun 14, 2012
Report 1818910-2012-15283 · MDR key 2625585
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Osteolysis
Narrative
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.
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED IN THE PRIMARY SURGERY.
Additional Manufacturer Narrative
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT CODE AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. IT WAS COMMUNICATED THAT NO ADDITIONAL INFORMATION WOULD BE MADE AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.