UNKNOWN DEPUY 41MM 3 PEG PATELLA
Received Jan 16, 2012 · Event occurred Dec 19, 2011
Report 1818910-2012-01093 · MDR key 2416626
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS PATELLA SHAVED OFF AT PEG LEVEL.
Additional Manufacturer Narrative
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFORMATION. IT WAS NOTED THE PRODUCT WAS IMPLANTED FOR APPROXIMATELY (B)(4) PRIOR TO REVISION. 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. (B)(4).
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.
Remedial action
- Other