BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM HUMERAL LINER +0

    MDR report key: 15241081 · Received August 17, 2022

    Report

    Report Number
    1038671-2022-00924
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 29, 2022
    Report Date
    January 20, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (DEVICE EVALUATED BY MFR)PENDING EVALUATION . CONCOMITANT DEVICE(S): 320-01-38 EQUINOXE REVERSE 38MM GLENOSPHERE S/N:(B)(4) K063569, 320-15-05 EQ REV LOCKING SCREW S/N:(B)(4) K063569, 300-01-15 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM S/N:(B)(4) K042021, 320-10-00 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 S/N:(B)(4) K063569, 320-20-00 EQ REVERSE TORQUE DEFINING SCREW KIT S/N:(B)(4) K063569, 320-15-01 - EQ REV GLENOID PLATE K063569.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND INJURY TO THE DEVICES AFTER A FALL THAT CAUSED A BROKEN GLENOID. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 MONTHS POST OP THE INITIAL RIGHT TSA, THIS 76 Y/O MALE PATIENT WAS REVISED DUE TO AN INFECTION. THE PATIENT FELL AND FRACTURED GLENOID. SURGEON REMOVED ALL PROSTHESES AND IMPLANTED CEMENT SPACER DUE TO POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712616 EQUINOXE REVERSE 38MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention