BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8757430 · Received July 3, 2019

    Report

    Report Number
    1038671-2019-00356
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    May 6, 2019
    Report Date
    April 30, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086723
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED OCCUPATION: PHYSICIAN PMA/510(K)NUMBER: K063569 THE REVISION REPORTED WAS LIKELY THE RESULT OF INCOMPLETE SEATING OF THE HUMERAL LINER DURING IMPLANTATION, FORCEFUL CONTACT BETWEEN THE HUMERAL LINER AND BONE (IMPINGEMENT/SCAPULAR NOTCHING), OR EXTREME WEAR OF THE HUMERAL LINER, WHICH LED TO THE HUMERAL LINER DISASSOCIATING FROM THE HUMERAL ADAPTER TRAY. DATE RECEIVED BY MANUFACTURER ¿ DATE ON INITIAL SUBMISSION SHOULD HAVE BEEN 06-MAY-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICES: 320-01-42, 137243008, 42 GLENOSPHERE; 320-10-00, 11172303, 0 ADAPTOR TRAY.

    Description of Event or Problem · 1

    DR. (B)(6) REVISED THIS PATIENT'S REVERSE SHOULDER DUE TO THE HUMERAL LINER THAT DISASSOCIATED FROM THE HUMERAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551505 EQUINOXE EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5 KWT EXACTECH, INC. UNK UNK 10885862086723

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R