BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM GLENOSPHERE

    MDR report key: 15502131 · Received September 29, 2022

    Report

    Report Number
    1038671-2022-01190
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    August 29, 2022
    Report Date
    January 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086396
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM 4006628, 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5 4018756, 320-15-01 - EQ REV GLENOID PLATE 4022980, 320-15-05 - EQ REV LOCKING SCREW 4019110, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 4007998, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM 3967635, 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM 3989234, 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM 4019449, 4019468, 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0 3925448.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF DISLOCATION AND HUMERAL LINER DISASSOCIATION. IT IS UNCLEAR IF THE DISLOCATION ALLOWED FOR THE HUMERAL LINER TO DISASSOCIATE OR IF THE HUMERAL LINER DISASSOCIATION-WHICH MAY HAVE BEEN THE RESULT OF EITHER INCOMPLETE SEATING OF THE LINER DURING IMPLANTATION, BONE IMPINGEMENT, PATIENT CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES-LED TO THE DISLOCATION AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION AND IMAGES/PRE-REVISION RADIOGRAPHS WERE UNABLE TO BE OBTAINED. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 4755, PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 70 YEARS POST OP THE INITIAL LEFT REVERSE TSA, THIS 70 Y/O MALE PATIENT WAS REVISED DUE TO DISLOCATION. THE POLY WAS DISASSOCIATED FROM THE TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING, PRODUCT WAS SENT TO SPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955578 EQUINOXE REVERSE 42MM GLENOSPHERE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-01-42 10081294 10885862086396

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention