OtherHTG
EXACTECH OPTETRAK
Received May 11, 2011 · Event occurred Feb 25, 2011
Report 1038671-2011-00057 · MDR key 2096453
Device
Product problems
- Device Slipped
Patient
Not reported
- Osteolysis
Narrative
Description of Event or Problem
REVISION OF KNEE COMPONENTS APPROXIMATELY 12 YEARS POST OPERATIVE DUE TO ASEPTIC LOOSENING/OSTEOLYSIS.
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORT COULD NOT BE DETERMINED AS THE EXPLANTED DEVICES WERE NOT RETURNED TO MANUFACTURER FOR EVALUATION. ADDITIONALLY, THE DEVICE SERIAL NUMBERS WERE NOT AVAILABLE PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.