UNKNOWN DEPUY 38 ROUND PATELLA
Received Mar 27, 2012 · Event occurred Feb 28, 2012
Report 1818910-2012-07627 · MDR key 2506345
Device
Product problems
- Insufficient Device Problem Information
Patient
67 YR
- Pain
- Osteolysis
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS PAIN AND OSTEOLYSIS.
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
THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. THE PRODUCT CODES AND LOT CODES REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCTS TO EXAMINE AND INSUFFICIENT PRODUCT INFORMATION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.