UNK DEPUY SMALL PATELLA
Received Nov 1, 2012 · Event occurred Aug 30, 2012
Report 1818910-2012-26274 · MDR key 2814480
Device
Generic name
Patella Implant
Catalog number
UNK
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
60 YR
- Pain
- Swelling
Narrative
Description of Event or Problem
PATIENT REPORTS THAT KNEE IMPLANT IS FAILING AND REVISION IS NEEDED, POSSIBLY LOOSE. THREE YEARS AGO KNEE BEGAN TO SWELL, TROUBLE GOING UP AND DOWN STAIRS, FALLS, TROUBLE BENDING AND PAIN.
Additional Manufacturer Narrative
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE PRODUCT CODES AND LOT CODES REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. A REQUEST FOR ADDITIONAL INVESTIGATIONAL INPUTS WAS CONDUCTED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE SUPPLIED 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.
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.