OtherHSH
OPTETRAK CONSTRAINED CONDYLAR TIBIAL INSERT
Received Feb 3, 2014 · Event occurred Nov 10, 2013
Report 1038671-2014-00018 · MDR key 3622177
Add to watch list
Product code (HSH)
Manufacturer (Exactech, Inc.)
Model (208-23-13)
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Sepsis
Narrative
Description of Event or Problem
REVISION OF OPTETRAK KNEE COMPONENTS REPORTEDLY DUE TO SEPSIS. THIS EVENT OCCURRED OUTSIDE OF THE US, IN (B)(6), AND WAS DISCOVERED THROUGH POST MARKET 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 IDENTIFICATION INFO WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.