BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM HUMERAL LINER +0

    MDR report key: 14943477 · Received July 7, 2022

    Report

    Report Number
    1038671-2022-00760
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    June 9, 2022
    Report Date
    February 23, 2023
    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

    PENDING EVALUATION. CONCOMITANT DEVICE(S): EQUINOXE REVERSE 38MM GLENOSPHERE - 320-01-38, 7131119; GLENOSPHERE LOCKING SCREW - 320-15-05, 7323389.

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

    Description of Event or Problem · 0

    AS REPORTED, 22 DAYS POST OP THE INITIAL RIGHT TSA, THIS 75 Y/O MALE PATIENT WAS REVISED DUE TO INFECTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING, DISPOSED OF BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723920 EQUINOXE REVERSE 38MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention SEE H10