BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13874422 · Received March 24, 2022

    Report

    Report Number
    1038671-2022-00275
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    March 1, 2022
    Report Date
    September 9, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079329
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 320-01-42, 3854482 - EQUINOXE REVERSE 42MM GLENOSPHERE. 320-10-00, 4195950 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-15-05, 4181502 - EQ REV LOCKING SCREW. 320-20-00, 4213897 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-42-03, 3912095 - EQUINOXE REVERSE 42MM HUMERAL LINER +2.5.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF INSUFFICIENT BONY SUPPORT FOR THE IMPLANT, PATIENT-RELATED CONDITIONS, OR A COMBINATION OF THESE POSSIBILITIES, WHICH LED TO HUMERAL STEM SUBSIDENCE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. 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 6 YEARS POST OP INITIAL LEFT TSA, THIS (B)(6) MALE PATIENT WAS REVISED DUE TO THE STEM BEING SUBSIDED. 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
    852695 EQUINOXE HUMERAL STEM PRIMARY, PRESS FIT 13MM KWT EXACTECH, INC. 300-01-13 UNK 10885862079329

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R SEE H10