UNKNOWN DEPUY PATELLA
Received Dec 11, 2012 · Event occurred Nov 20, 2012
Report 1818910-2012-83389 · MDR key 2867547
Device
Generic name
Patella Prosthesis
Manufacturer
Depuy Orthopaedics, Inc.Catalog number
UNK-KNEE
Lot number
UNKNOWN
Product problems
- Naturally Worn
Patient
69 YR
- Pain
- Osteolysis
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, MINIMAL POLY WEAR ON THE PATELLA, AND MALPOSITIONING AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE, WITH PAIN AND INSTABILITY. COMPETITOR CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.
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 WERE 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 ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. 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.