BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13634045 · Received March 1, 2022

    Report

    Report Number
    1038671-2022-00231
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    October 16, 2019
    Report Date
    June 15, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION . CONCOMITANT MEDICAL PRODUCTS: 320-15-01, 5222680 - EQ REV GLENOID PLATE. 320-01-38, 5237307 - EQUINOXE REVERSE 38MM GLENOSPHERE. 320-10-00, 5253917 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-20-26, 5280360 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 320-20-22, 5285155 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. 320-20-26, 5285237 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 320-20-22, 5288013 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. 320-20-00, 5288766 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-15-05, 5300560 - EQ REV LOCKING SCREW.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) UPON REVIEW, THERE IS NO ALLEGATION AGAINST THE DEVICE AS THE REASON FOR REVISION WAS NOT REPORTED. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT CONDITIONS.

    Description of Event or Problem · 0

    THIS REVISION WAS FOUND DURING THE INVESTIGATION OF (B)(4). REASON FOR THE REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304737 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H