InjuryHTG
UNKNOWN DEPUY PATELLA
Received Jun 22, 2012 · Event occurred Jun 14, 2012
Report 1818910-2012-15284 · MDR key 2625707
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Osteolysis
Narrative
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
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.