UNKNOWN DEPUY STD PATELLA
Received Aug 7, 2012 · Event occurred Aug 1, 2012
Report 1818910-2012-18661 · MDR key 2685531
Device
Generic name
Patella Prosthesis
Catalog number
UNK
Lot number
UNKNOWN
Product problems
- Naturally Worn
Patient
60 YR
- No Information
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS POLY WEAR OF MENISCAL BEARINGS AND PATELLA.
Additional Manufacturer Narrative
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED IN SEARCHING THE COMPLAINT DATABASE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFORMATION; HOWEVER, WEAR OF A POLYETHYLENE KNEE DEVICE AFTER TWENTY-ONE YEARS IMPLANTATION IS NOT UNEXPECTED. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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.
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.