UNKNOWN DEPUY SZ4 10MM CVD INSERT
Received Nov 8, 2010 · Event occurred Oct 12, 2010
Report 1818910-2010-08088 · MDR key 1895158
Device
Generic name
Total Knee Prosthesis
Manufacturer
Depuy Orthopaedics, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Naturally Worn
Patient
NA
- Osteolysis
Narrative
Additional Manufacturer Narrative
THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. THE PRODUCT CODES AND LOT CODES 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 PRODUCTS 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 ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem
PT WAS REVISED TO ADDRESS MEDIAL-POSTERIOR SUBSIDENCE OF TIBIAL TRAY. "NORMAL" POLY WEAR AND OSTEOLYSIS WERE ALSO REPORTED.
Remedial action
- Other