UNKNOWN DEPUY PATELLA
Received Jan 17, 2012 · Event occurred Dec 18, 2011
Report 1818910-2012-01485 · MDR key 2418341
Device
Product problems
- Mechanical Problem
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS PATELLA CLUNK. SCAR TISSUE WAS REMOVED AND THE INSERT EXCHANGED, BUT NO OTHER COMPONENTS WERE 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 PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. 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; HOWEVER, THE INITIAL REPORTING SUGGESTS PATIENT SCAR TISSUE WAS A CONTRIBUTING FACTOR. 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.
Additional Manufacturer Narrative
CORRECTION: THIS FIELD SHOWED AN EXPLANT DATE OF (B)(6) 2011 ON THE INITIAL EMDR, BUT SHOULD HAVE BEEN BLANK, SINCE THE DEVICE WAS NOT REMOVED.
Remedial action
- Other