UNKNOWN DEPUY PFC PATELLA
Received Mar 13, 2012 · Event occurred Feb 13, 2012
Report 1818910-2012-06039 · MDR key 2489861
Device
Product problems
- Naturally Worn
Patient
87 YR
- Pain
Narrative
Additional Manufacturer Narrative
(B)(4). THE CUSTOMER REPORTS THE PATIENT WAS REVISED TO ADDRESS POLY WEAR AND PAIN. DOI: 1993-DOR: (B)(6) 2012 (L KNEE). 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.
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 POLY WEAR AND PAIN.
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.