OtherHSH
OPTETRAK
Received Nov 3, 2010
Report 1038671-2010-00165 · MDR key 1892852
Device
Generic name
Cemented Finned Tibial Tray
Manufacturer
Exactech, Inc.Catalog number
200-04-22
Lot number
10130684
Product problems
- Device Slipped
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
REVISION DUE TO TIBIAL LOOSENING.
Additional Manufacturer Narrative
ENGINEERING EVALUATION OF THE RETURNED TIBIAL TRAY NOTED THAT THE TIBIAL STEM WAS PRISTINE. THERE IS BURNISHING PRESENT ON THE BOTTOM SURFACE CONSISTENT WITH MICROMOTION BETWEEN THE BONE AND TIBIAL COMPONENT.