BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13389874 · Received January 29, 2022

    Report

    Report Number
    1038671-2022-00075
    Event Type
    Injury
    Date Received
    January 29, 2022
    Date of Event
    January 5, 2022
    Report Date
    March 22, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 300-62-03, 03140822 - STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 3; 310-60-47, 104875004 - STEMLESS HUMERAL HEAD EXTRA SHORT, 47MM (BETA).

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF FAILURE OF THE CAGE GLENOID COMPONENT. POSSIBLE CONTRIBUTING FACTORS INCLUDE BUT ARE NOT LIMITED TO INCOMPLETE OR OFF-AXIS SEATING OF THE GLENOID COMPONENT AT THE TIME OF IMPLANTATION, PATIENT CONDITIONS, AND/OR A POST TRAUMATIC EVENT. THE ROOT CAUSE OF THE FAILURE CANNOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (F10) ADVERSE EVENT PROBLEM: PLEASE DISREGARD. THESE WERE ENTERED IN ERROR.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL LEFT TSA, THIS (B)(6) MALE PATIENT WAS REVISED DUE TO THE GLENOID SHEARING OFF THE CENTRAL PEG. THE PEGS REMAINED IN BONE AND THE POLY DISASSOCIATED FROM THEM. THE SURGEON REVISED THIS PATIENT TO A BIOMET MINI BASEPLATE AND GLENOSPHERE AND EQUINOXE STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762975 EQUINOXE L POSTERIOR AUG KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention| H SEE H10