InjuryHSH
OPTETRAK HI-FLEX TIBIAL INSERT, POSTERIOR
Received Jun 4, 2014 · Event occurred Apr 13, 2014
Report 1038671-2014-00186 · MDR key 3877897
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVAL. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFO WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.
Description of Event or Problem
KNEE REVISION DUE TO TIBIAL SUBSIDENCE. THIS EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES AND WAS DISCOVERED DURING ACTIVE SURVEILLANCE FOR THE (B)(4) REGISTRY.