UNKNOWN DEPUY STD+ PATELLA POLY
Received Dec 10, 2012 · Event occurred Nov 30, 2012
Report 1818910-2012-83332 · MDR key 2864692
Device
Generic name
Patella Prosthesis
Manufacturer
Depuy Orthopaedics, Inc.Catalog number
UNK-KNEE
Lot number
UNKNOWN
Product problems
- Naturally Worn
Patient
85 YR
- Unspecified Infection
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS INFECTION AND POLY WEAR OF THE MESCAL BEARINGS AND PATELLA.
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 LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE; HOWEVER, WEAR OF A POLYETHYLENE DEVICE AFTER BEING IMPLANTED FOR APPROXIMATELY TWENTY-YEARS SHOULD NOT BE UNEXPECTED. INFECTION AFTER THE REPORTED PERIOD OF TIME IS UNLIKELY TO BE PRODUCT RELATED. BASED ON THE INABILITY TO IDENTIFY 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.