LCS 3 PEG ROT PATELLA CEM STD
Received Feb 20, 2013 · Event occurred Sep 15, 2008
Report 1818910-2013-12621 · MDR key 2970275
Device
Generic name
Patella
Manufacturer
1818910 Depuy Orthopaedics, Inc.Catalog number
177983025
Lot number
U18C71018
Product problems
- Naturally Worn
Patient
70 YR
- No Information
Narrative
Description of Event or Problem
PATIENT'S MEDICAL RECORDS RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS A FAILED KNEE IMPLANT. UPON REVISION POLYWEAR OF THE PATELLA WAS FOUND.
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.
Additional Manufacturer Narrative
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. THE INVESTIGATION DID NOT REVEAL ANY EVIDENCE SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND 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.