BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20559013 · Received October 29, 2024

    Report

    Report Number
    1038671-2024-04167
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    July 25, 2024
    Report Date
    October 29, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-01-12 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM: A850461; 320-36-00 - 145-DEG PE 36MM HUM LINER +0: A596230; 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: A855707; 320-31-36 - GLENOSPHERE, 36MM: A620024; 320-35-03 - SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT: A835060.

    Description of Event or Problem · 0

    APPROXIMATELY 6 MONTH(S) POST-OPERATIVE OF A LEFT TSA, THE PATIENT PRESENTED WITH SENSORIMOTOR DEFICIT. THE PATIENT COMPLAINS OF DECREASED MOBILITY IN THE WRIST OF THE SURGICAL ARM. NO ACTIONS WERE TAKEN ON BEHALF OF THE PATIENT AND THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922894 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Other