UNKNOWN DEPUY PATELLA
Received Mar 12, 2013 · Event occurred Sep 5, 2012
Report 1818910-2013-04216 · MDR key 2999385
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
56 YR
- Pain
Narrative
Additional Manufacturer Narrative
**UPDATE** 02/15/2013 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION PATELLA BAJA WAS FOUND. THE FEMORAL AND PATELLA WERE ADDED TO THE COMPLAINT AND THE COMPLAINT WAS RE-OPENED. MEDICAL RECORDS AND X-RAYS WERE OBTAINED AND REVIEWED. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE FOR THE NEWLY ADDED PRODUCTS WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE PROVIDED INFORMATION. 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.
Description of Event or Problem
CLINICAL REPORT STATES: ASEPTIC LOOSENING OF THE TIBIAL TRAY. **UPDATE** (B)(4) 2013 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION PATELLA BAJA WAS FOUND. THE FEMORAL AND PATELLA WERE ADDED TO THE COMPLAINT AND THE COMPLAINT WAS RE-OPENED.
Additional Manufacturer Narrative
THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING INFORMATION ON FEMORAL AND PATELLA. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.
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.