UNKNOWN DEPUY PATELLA
Received Sep 13, 2013 · Event occurred Aug 27, 2013
Report 1818910-2013-27374 · MDR key 3346705
Device
Generic name
Patella
Manufacturer
1818910 Depuy Orthopaedics, Inc.Catalog number
UNK-KNEE
Lot number
UNKNOWN
Product problems
- Naturally Worn
Patient
61 YR
- No Information
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS POLY WEAR.
Additional Manufacturer Narrative
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEW AND/OR SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
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.