UNKNOWN DEPUY 3-PEG OVAL DOME PATELLA
Received Aug 10, 2012 · Event occurred Aug 7, 2012
Report 1818910-2012-18721 · MDR key 2690330
Device
Generic name
Patella Prosthesis
Catalog number
UNK
Lot number
UNK
Product problems
- Noise, Audible
Patient
87 YR
- Scar Tissue
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS PATELLA CLUNK. SCAR TISSUE WAS REMOVED.
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 (B)(4) APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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.