UNKNOWN DEPUY PATELLA
Received Aug 23, 2012 · Event occurred Aug 20, 2012
Report 1818910-2012-18372 · MDR key 2711109
Device
Product problems
- Naturally Worn
Patient
88 YR
- No Information
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS POLY WEAR OF THE INSERT AND PATELLA. (RIGHT KNEE).
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. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED POLYETHYLENE WEAR BASED ON THE LACK OF THE PRODUCT TO EXAMINE; HOWEVER, WEAR OF A POLYETHYLENE KNEE DEVICE AFTER FIFTEEN YEARS IMPLANTATION SHOULD NOT BE UNEXPECTED. 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.