UNKNOWN DEPUY PATELLA
Received Jul 8, 2011 · Event occurred Jun 14, 2011
Report 1818910-2011-12642 · MDR key 2163231
Device
Generic name
Total Knee Prosthesis
Manufacturer
Depuy Orthopaedics, Inc.Model number
NACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Insufficient Device Problem Information
Patient
71 YR
- Unspecified Infection
Narrative
Description of Event or Problem
PATIENT WAS REVISED TO ADDRESS INFECTION.
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 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.
Remedial action
- Other