BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 14631518 · Received June 8, 2022

    Report

    Report Number
    1038671-2022-00646
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    March 28, 2022
    Report Date
    January 4, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862515780
    PMA / PMN Number
    K162726
    Adverse Event
    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): 320-06-38, 7063923 - GLENOSPHERE 38MM. 320-10-00, 7052245 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-38-00, UNKNOWN - EQUINOXE REVERSE 38MM HUMERAL LINER +0. 320-06-38, 7063923 - GLENOSPHERE 38MM.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE HUMERAL STEM AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) HUMERAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND PRE-REVISION X-RAYS WERE UNABLE TO BE OBTAINED. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 7455, PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS (B)(6) MALE PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO LOOSENING. THE PATIENT'S PRESERVE STEM APPEARED TO BE LOOSE AT TIME OF REVISION. SURGEON REMOVED EXISTING EXACTECH IMPLANTS AND REPLACED THEM WITH A 42+4 GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22688 EQUINOXE PRESERVE STEM 10MM KWT EXACTECH, INC. 300-30-10 UNK 10885862515780

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H SEE H10