UNKNOWN DEPUY PATELLA
Received Jun 28, 2011 · Event occurred Jun 3, 2011
Report 1818910-2011-11588 · MDR key 2149383
Device
Generic name
Total Knee Replacement
Manufacturer
Depuy Orthopaedics, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Loss of Osseointegration
Patient
62 YR
- No Information
Narrative
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 BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFO. 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 ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem
PT WAS REVISED TO ADDRESS FEMORAL AND PATELLA LOOSENING.
Remedial action
- Other