BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8931954 · Received August 26, 2019

    Report

    Report Number
    1038671-2019-00426
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    August 15, 2019
    Report Date
    November 5, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862242594
    PMA / PMN Number
    K140063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (G5) PMA/510(K)NUMBER: K140063. (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN, MANUFACTURING, OR PATIENT RELATED ISSUES. THE CAUSE OF THE INFECTION IS MOST LIKELY IS RELATED TO THE PATIENT¿S UNDERLYING CONDITION. (H4) DEVICE MANUFACTURE DATE: 03-JAN-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE(S): TORQUE SCREW (CAT# 300-20-02 / SN# (B)(4)); SHORT REPLICATOR PLATE (CAT# 300-50-45 / SN# (B)(4)); SMALL CAGED GLENOID (CAT# 314-13-02 / SN# (B)(4)); 9MM STEM (CAT# 300-01-09 / SN# (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE SURGEON EXPLANTED IT AND PUT IN AN ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726455 EQUINOXE XS HUMERAL HEAD, 44MM XS OFFSET HUMERAL HEAD KWT EXACTECH, INC. 10885862242594

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R