UNKNOWN DEPUY PATELLA
Received Feb 27, 2013 · Event occurred Feb 12, 2013
Report 1818910-2013-12892 · MDR key 2980709
Device
Generic name
Patella Prosthesis
Manufacturer
Depuy Orthopaedics, Inc. 1818910Catalog number
UNK-KNEE
Lot number
UNKNOWN
Product problems
- Naturally Worn
Patient
60 YR
- Pain
Narrative
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 AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED POLYETHYLENE WEAR WITHOUT THE PRODUCT TO EXAMINE. 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.
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
DURING A REVISION TO ADDRESS A KNEE THAT WAS PAINFUL AND LAX, POLY WEAR OF THE PATELLA WAS ALSO FOUND.