BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 10706597 · Received October 20, 2020

    Report

    Report Number
    1038671-2020-00582
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 20, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862283023
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH MAY HAVE BEEN DUE TO THE SUSPECTED INFECTION, LEADING TO LOOSENING OF THE HUMERAL STEM. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION. CONCOMITANT DEVICE(S): 320-38-10,5260321 - EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0; 320-02-38, 5118417 - RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET; 320-10-00, 6119088 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; 320-15-05, 6112259 - EQ REV LOCKING SCREW; 320-20-00, 6027501 - EQ REVERSE TORQUE DEFINING SCREW KIT.

    Description of Event or Problem · 1

    APPROXIMATELY 13 MONTHS POSTOP THE INITIAL RIGHT TSA, THIS FEMALE PATIENT PRESENTED WITH A LOOSE HUMERAL COMPONENT FROM A SUSPECTED INFECTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171552 EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0 KWT EXACTECH, INC. 300-01-14 UNK 10885862283023

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R