BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE GLENOSPHERE

    MDR report key: 3981479 · Received July 25, 2014

    Report

    Report Number
    1038671-2014-00301
    Event Type
    Injury
    Date Received
    July 25, 2014
    Report Date
    July 23, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    REVISION DUE TO SEPTIC ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436760 EQUINOXE REVERSE GLENOSPHERE REVERSE GLENOSPHERE KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O