BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12420650 · Received September 3, 2021

    Report

    Report Number
    1038671-2021-00459
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    August 13, 2021
    Report Date
    March 16, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    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

    SECTION H10: (D4) UNIQUE IDENTIFIER (UDI) #: (B)(4). (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: 320-20-00, 6958760 - EQ REVERSE TORQUE DEFINING SCREW KIT, 320-15-05, 6922670 - EQ REV LOCKING SCREW, 321-20-00, 6927960 - EQUINOXE REVERSE SHOULDER DRILL KIT, 320-15-03, 6774957 - RS GLENOID PLATE POST AUG, 8 DEG, LEFT, 320-01-38, 6934239 - EQUINOXE REVERSE 38MM GLENOSPHERE, 300-01-15, 6749952 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM, 320-10-00, 6933200 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 11 DAYS POSTOP THE INITIAL TSA, A REVISION WAS COMPLETED DUE TO INFECTION. THE LINER WAS CHANGED AFTER THE WASH OUT. THE MALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNED, DISPOSE BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320903 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

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