BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUINOXE SHOULDER SYSTEM

    MDR report key: 3842542 · Received February 24, 2014

    Report

    Report Number
    1038671-2014-00046
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    October 23, 2013
    Report Date
    February 24, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    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 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 · 1

    REVISION OF EQUINOXE SHOULDER COMPONENTS DUE TO INFECTION. THIS EVENT WAS REPORTED THROUGH CLINICAL DATA COLLECTION AND IT IS NOT KNOWN IF THE SURGEON CONSIDERED THE EVENT TO BE DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112237 EQUINOXE SHOULDER SYSTEM TOTAL SHOULDER KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R