BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9804986 · Received March 9, 2020

    Report

    Report Number
    1038671-2020-00241
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    February 26, 2020
    Report Date
    September 21, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086396
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (E1) COUNTRY: (B)(6). (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION CONCOMITANT DEVICE(S): CN:320-15-05, SN: 6111622: EQ REV LOCKING SCREW; CN:320-42-00, SN: 6072878; EQUINOXE REVERSE 42MM HUMERAL LINER +0; CN:320-10-00, SN: 6246238; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; CN:320-20-00, SN: 6237917; EQ REVERSE TORQUE DEFINING SCREW KIT.

    Description of Event or Problem · 1

    APPROXIMATELY 3 MONTHS AFTER THE INITIAL LEFT TSA, THE (B)(6) Y/O MALE PATIENT WAS REVISED DUE TO INFECTION. THE GLENOSPHERE, GLENOSPHERE SCREW, LINER AND TRAY WERE REMOVED TO WASH OUT. NEW COMPONENTS PUT BACK IN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270866 EQUINOXE REVERSE 42MM GLENOSPHERE KWT EXACTECH, INC. 320-01-42 UNK 10885862086396

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R