UNKNOWN DEPUY PATELLA
Received May 20, 2011 · Event occurred Apr 21, 2011
Report 1818910-2011-09003 · MDR key 2113271
Device
Generic name
Total Knee Replacement
Manufacturer
Depuy Orthopaedics, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
62 YR
- Osteolysis
Narrative
Additional Manufacturer Narrative
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. PROVIDED INFORMATION STATED, THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR BEING CONTRIBUTING FACTORS TO THE EVENT. 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 REC'D, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem
PT REVISED FOR HYPEREXTENSION AND LAXITY. OSTEOLYSIS WAS NOTED.
Remedial action
- Other