BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13423603 · Received February 2, 2022

    Report

    Report Number
    1038671-2022-00136
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    January 14, 2022
    Report Date
    June 16, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086662
    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

    DEVICE EVALUATED BY MFR: PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-01-13, 6850563 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM, 320-10-00, 6862676 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 320-15-01, 6887213 - EQ REV GLENOID PLATE, 320-15-05, 6896642 - EQ REV LOCKING SCREW, 320-20-00, 6895957 - EQ REVERSE TORQUE DEFINING SCREW KIT, 320-20-26, S214748 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, 320-20-30, S222366 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 320-02-38, 6574296 - RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET.

    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 THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATLY 8 MONTHS POST OP RTSA, THIS 80 Y/O MALE PATIENT WAS REVISED DUE TO AN INFECTION. THE SURGEON WASHED OUT AND EXCHANGED THE LINER, ADAPTER TRAY AND GLENOSPHERE. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO THE HOSPITAL DISPOSING OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114087 EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 KWT EXACTECH, INC. 320-38-03 UNK 10885862086662

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| H SEE H10