OtherHTG
OPTETRAK THREE PEG PATELLA
Received Jan 15, 2014 · Event occurred Sep 25, 2013
Report 1038671-2014-00003 · MDR key 3597938
Device
Product problems
- Loose or Intermittent Connection
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 US, IN (B)(6), AND WAS DISCOVERED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORT COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVAL.