BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13541692 · Received February 16, 2022

    Report

    Report Number
    1038671-2022-00200
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    January 27, 2022
    Report Date
    February 23, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 320-01-42, 6917440: EQUINOXE REVERSE 42MM GLENOSPHERE, 320-15-02, 7061786: RS GLENOID PLATE SUP AUG, 10 DEG, 320-15-05, 7121680: EQ REV LOCKING SCREW, 320-20-18, S317417: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM, 320-10-00, 6751066: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 300-01-13, 6962114: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM, 320-20-00, 7122266: EQ REVERSE TORQUE DEFINING SCREW KIT.

    Additional Manufacturer Narrative · 0

    SECTION H10: (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 SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 MONTHS POST OP INITIAL RTSA, THIS (B)(6) MALE PATIENT WAS REVISED DUE TO AN INFECTION. THERE WAS A 15-30 MIN DELAY, THERE WAS NO ADVERSE EVENTS AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY, COMPONENTS WERE IN VERY GOOD SHAPE WITH NIL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8780 EQUINOXE REVERSE 42MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-42-00 UNK 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization| R SEE H10