UNKNOWN DEPUY PATELLA
Received Apr 16, 2012 · Event occurred Mar 21, 2012
Report 1818910-2012-10067 · MDR key 2537017
Device
Product problems
- Insufficient Device Problem Information
Patient
79 YR
- Unspecified Infection
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS INFECTION. SPACERS WERE IMPLANTED IN (B)(6) 2012 AND AGAIN ON (B)(6) 2012 DUE TO ONGOING INFECTION. REP WAS NOT AWARE OF THESE SURGERIES UNTIL (B)(6) 2012, WHEN KNEE WAS RE-IMPLANTED. (LEFT KNEE).
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. 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 PATIENT KNEE INFECTION 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.