BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 3190207 · Received June 18, 2013

    Report

    Report Number
    1038671-2013-00055
    Event Type
    Other
    Date Received
    June 18, 2013
    Date of Event
    February 11, 2013
    Report Date
    June 18, 2013
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE REPORTED EXPERIENCE COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND IT IS NOT REPORTED WHAT FACTORS LED TO THE DEVICES BEING UNDERSIZED IN THE PRIMARY SURGERY. PROPERLY FUNCTIONING IMPLANTS DEPEND ON APPROPRIATE DIMENSIONING COMPARED TO THE NATIVE BONE. IF GROSSLY UNDERSIZED, THE TIBIAL BASEPLATE MAY LOSE THE EXPECTED SUPPORT FROM THE CORTICAL SHELL OF THE PROXIMAL TIBIA AND, AS A RESULT, SUBSIDE.

    Description of Event or Problem · 1

    REVISION DUE TO UNDER - SIZING OF THE TIBIAL COMPONENTS DURING PRIMARY SURGERY. THIS EVENT OCCURRED OUTSIDE OF THE US, IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277178 OPTETRAK TIBIAL INSERT JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention