OtherHSH
OPTETRAK
Received Nov 21, 2012 · Event occurred Sep 5, 2012
Report 1038671-2012-00133 · MDR key 2849262
Device
Generic name
Cemented Trapezoid Tibial Tray
Manufacturer
Exactech, Inc.Product problems
- Device Slipped
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
REVISION OF KNEE COMPONENTS DUE TO TIBIAL LOOSENING. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES IN (B)(6).
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE SPECIFIC DEVICE INFORMATION WAS NOT PROVIDED PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.