UNKNOWN DEPUY LCS PATELLA
Received May 12, 2011 · Event occurred Apr 12, 2011
Report 1818910-2011-08328 · MDR key 2093663
Device
Generic name
Total Knee Replacement
Manufacturer
Depuy Orthopaedics, Inc.Model number
NACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Malposition of Device
Patient
77 YR
- No Information
Narrative
Additional Manufacturer Narrative
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED POOR DEVICE TRACKING BASED ON THE PROVIDED INFORMATION. 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.
Description of Event or Problem
PATIENT REVISED FOR POOR PATELLA TRACKING.
Remedial action
- Other