BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM GLENOSPHERE

    MDR report key: 16915265 · Received May 11, 2023

    Report

    Report Number
    1038671-2023-00975
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    March 21, 2023
    Report Date
    November 22, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086389
    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

    H2: THIS EVENT WAS DETERMINED TO BE A DUPLICATE OF A CASE REPORTED UNDER: 1038671-2023-00965.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 4889713, 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. 4804237, 315-35-00 - GLND KWIRE. 4917471, 315-35-00 - GLND KWIRE. 5092937, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. .5014300, 320-15-04 - RS GLENOID PLATE POST AUG, 8 DEG, RIGHT. 4957307, 320-15-05 - EQ REV LOCKING SCREW. 5075494, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. 4988872, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 5012648, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 4550033, 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 5091619, 320-38-03 - EQUINOXE REVERSE 38MM HUMERAL LINER +2.5. 8011017076, A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO INSTABILITY. THERE WAS NO REPORTED BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424356 EQUINOXE REVERSE 38MM GLENOSPHERE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-01-38 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention SEE H10.