UNKNOWN DEPUY LCS PATELLA
Received May 14, 2012 · Event occurred Apr 26, 2012
Report 1818910-2012-12528 · MDR key 2572641
Device
Product problems
- Malposition of Device
- Naturally Worn
- Appropriate Device Problem Term/Code Not Available
Patient
56 YR
- No Information
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS AN EVERTED, MALFUNCTIONING AND MODERATELY WORN PATELLA.
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. EXAMINATION OF SUPPLIED X-RAYS SUGGESTS THE PATELLAR COMPONENT IS EVERTED. 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 ROOT CAUSE OF THE EVERTED PATELLA. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. 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.