UNKNOWN DEPUY 38MM PATELLA
Received Sep 17, 2012 · Event occurred Sep 11, 2012
Report 1818910-2012-21072 · MDR key 2747160
Device
Generic name
Patella Prosthesis
Catalog number
UNK
Lot number
UNK
Product problems
- Naturally Worn
Patient
61 YR
- Osteolysis
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, POLY WEAR, AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE/CEMENT INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF IMPLANTATION.
Additional Manufacturer Narrative
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED
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.