MalfunctionHSH
OPTETRAK TIBIAL TRAY
Received Jun 19, 2015 · Event occurred Oct 30, 2015
Report 1038671-2015-00265 · MDR key 4863134
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Fall
Narrative
Description of Event or Problem
INDEX SURGERY:(B)(6) 2009. REVISION OF OPTETRAK KNEE COMPONENTS DUE TO PATIENT FALL. THIS EVENT OCCURRED OUTSIDE OF THE US, IN (B)(6), 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.