BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 10430662 · Received August 20, 2020

    Report

    Report Number
    1038671-2020-00502
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    August 11, 2020
    Report Date
    November 18, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079305
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 320-42-03, 5443093, EQUINOXE REVERSE SHOULDER LINER 42MM +2.5. 320-01-42, 5536763, EQUINOXE REVERSE SHOULDER GLENOSPHERE 42MM. 320-10-00, 5546035, EQUINOXE REVERSE SHOULDER HUMERAL ADAPTOR TRAY +0MM. 320-15-05, 5527733, EQUINOXE REVERSE SHOULDER GLENOSPHERE LOCKING SCREW. 315-35-00, 5160934, GLND KWIRE. 321-20-00, 5241024, EQUINOXE REVERSE SHOULDER DRILL KIT. 320-15-01, 5497446, EQUINOXE REVERSE GLENOID PLATE. 320-20-00, 5548201, EQUINOXE REVERSE TORQUE DEFINING SCREW KIT. 320-20-30, 5553362, EQUINOXE REVERSE COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 320-20-30, 5551326, EQUINOXE REVERSE COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 320-20-30, 5552922, EQUINOXE REVERSE COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 2 YEARS POST-OP THE INITIAL LEFT TSA, THIS (B)(6) Y/O FEMALE PATIENT HAS HUMERAL STEM LOOSENING ON ROTATION, INFECTION WAS FOUND DURING THE REVISION AND IS THE OFFICIAL DIAGNOSIS. 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
    893694 EQUINOXE HUMERAL STEM PRIMARY, PRESS FIT 9MM KWT EXACTECH, INC. 300-01-09 UNK 10885862079305

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R SEE H10