inforMED
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.