InjuryHSH
OPTETRAK ALL POLY TIBIAL COMPONENT
Received Jun 9, 2014
Report 1038671-2014-00268 · MDR key 3889092
Device
Generic name
All Poly Tibial Component
Manufacturer
Exactech, Inc.Product problems
- Fracture
- Loose or Intermittent Connection
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
REVISION OF KNEE COMPONENTS DUE TO TIBIAL LOOSENING AND A FRACTURED ANTERIOR TIBIA WITH THE INSERTION OF A STEMMED TIBIA. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.
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 INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.