MalfunctionHSH
OPTETRAK HI-FLEX TIBIAL INSERT
Received Sep 15, 2014 · Event occurred Aug 21, 2014
Report 1038671-2014-00429 · MDR key 4177441
Device
Product problems
- Loose or Intermittent Connection
Patient
Not reported
- Pain
Narrative
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. FURTHER, DEVICE SPECIFIC INFO WAS NOT PROVIDED, PRECLUDING A DEVICE HISTORY RECORD SEARCH.
Description of Event or Problem
REVISION DUE TO PAIN AND LOOSENING. DURING REVISION, IT WAS NOTED THERE WAS NO CEMENT MANTLE ON FEMUR OR TIBIAL TRAY.