BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13634062 · Received March 1, 2022

    Report

    Report Number
    1038671-2022-00232
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    June 19, 2021
    Report Date
    June 15, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862535047
    PMA / PMN Number
    K180632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 320-32-40, 5993404 - EXPANDED GLENOSPHERE, 40MM, FOR SMALL REVERSE. 320-35-01, 6066265 - SMALL GLENOID PLATE. 300-01-15, 6113495 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM. 320-20-34, 6171767 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 320-10-00, 6203171 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-15-05, 6217400 - EQ REV LOCKING SCREW. 320-20-00, 6224120 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-20-30, 6225658 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM.

    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
    1304753 EQUINOXE HUMERAL LINER, 40MM, +2.5 KWT EXACTECH, INC. 320-40-03 UNK 10885862535047

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H