UNKNOWN DEPUY LCS STD 3-PEG PATELLA
Received Jun 18, 2012 · Event occurred Jun 13, 2012
Report 1818910-2012-14496 · MDR key 2618909
Device
Product problems
- Naturally Worn
Patient
52 YR
- No Information
Narrative
Description of Event or Problem
DURING A REVISION TO ADDRESS DISASSOCIATION OF THE POLY PORTION OF THE PATELLA FROM THE METAL BACK DUE TO TRAUMA TO THE KNEE, POLY WEAR WAS ALSO 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. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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.