OtherHSH
OPTETRAK
Received Nov 21, 2012 · Event occurred Sep 27, 2012
Report 1038671-2012-00136 · MDR key 3136341
Device
Generic name
Posterior Stabilized Tibial Insert
Manufacturer
Exactech, Inc.Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
REVISION OF KNEE COMPONENTS DUE TO TIBIAL SUBSIDENCE. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES IN FRANCE. PRIMARY DATE OF SURGERY WAS IN 2007.
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.