BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 11924463 · Received June 2, 2021

    Report

    Report Number
    1038671-2021-00276
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 2, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079312
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISION REPORTED WAS LIKELY 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 DEVICE WAS NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICE(S): 320-10-00, 6017460 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-15-05, 5989141 - EQ REV LOCKING SCREW. 320-15-03, 5860146 - RS GLENOID PLATE POST AUG, 8 DEG, LEFT. 320-01-38, 5909506 - EQUINOXE REVERSE 38MM GLENOSPHERE. 320-20-00, 6037702 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-38-00, 6013112 - EQUINOXE REVERSE 38MM HUMERAL LINER +0. 320-20-34, 5988195 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 320-20-30, 5804372 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 21 MONTHS AFTER THE INITIAL L TSA, THIS (B)(6) Y/O FEMALE PATIENT EXPERIENCED HUMERAL PRESS FIT STEM LOOSENING AND WAS REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WAS DISPOSED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821801 EQUINOXE HUMERAL STEM PRIMARY, PRESS FIT 11MM KWT EXACTECH, INC. 300-01-11 UNK 10885862079312

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R