MalfunctionHSH
OPTETRAK TIBIAL TRAY
Received Jun 19, 2015 · Event occurred Aug 8, 2014
Report 1038671-2015-00261 · MDR key 4863164
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
INDEX SURGERY: (B)(6) 2014. REVISION OF OPTETRAK KNEE COMPONENTS - REASON NOT REPORTED. THIS EVENT OCCURRED OUTSIDE OF THE US, IN FRANCE, AND WAS DISCOVERED AS PART OF ACTIVE SURVEILLANCE.
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.