BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 10425341 · Received August 19, 2020

    Report

    Report Number
    1038671-2020-00495
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    August 6, 2020
    Report Date
    November 18, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    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 MEDICAL PRODUCTS: 320-15-01, 5766134, RS GLENOID PLATE POST AUG, 8 DEG, LEFT. 320-15-05, 6252982, EQ REV LOCKING SCREW. 320-01-38, 6211877, EQUINOXE REVERSE 38MM GLENOSPHERE. 320-10-00, 6263583, EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-20-00, 6196263, EQ REVERSE TORQUE DEFINING SCREW KIT. 300-01-11, 6255158, EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM. 320-20-38, 6006269, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 320-20-26, 6183498, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 320-20-22, 6155090, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. 320-20-18, 6063613, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM.

    Description of Event or Problem · 1

    APPROXIMATELY 9 MONTHS POST-OP THE INITIAL LEFT TSA, THE FEMALE PATIENT WAS REVISED FOR INFECTION. ALL IMPLANTS WERE REMOVED, AND A ANTIBIOTIC INFUSED SPACER WAS INSERTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890795 EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 KWT EXACTECH, INC. 320-38-03 UNK 10885862086662

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R