UNKNOWN DEPUY PATELLA
Received May 30, 2012
Report 1818910-2012-08596 · MDR key 2592343
Device
Product problems
- Break
Patient
70 YR
- No Information
Narrative
Description of Event or Problem
CLINICAL REPORT STATES THE PATIENT WAS REVISED BECAUSE OF IMPLANT FRACTURE.
Additional Manufacturer Narrative
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. RADIOGRAPHS WERE NOT AVAILABLE FOR REVIEW. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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.