BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 17144860 · Received June 16, 2023

    Report

    Report Number
    1038671-2023-01380
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    April 15, 2023
    Report Date
    May 11, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086372
    PMA / PMN Number
    K093275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

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

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): A217653 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM. A053732 320-01-36 - 36MM GLENOSPHERE. A227904 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. A213921 320-15-01 - EQ REV GLENOID PLATE. A145777 320-15-05 - EQ REV LOCKING SCREW. A140513 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. A091112 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 MONTHS POST OP INITIAL TSA, THIS 86 Y/O FEMALE PATIENT WAS REVISED. SURGEON HAD SUSPECTED INFECTION DUE TO RAISED CRP AND LFT. ONCE IMPLANTS WERE REMOVED AND SAMPLES TAKEN, NO INFECTION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481717 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086372

    Patients

    Seq Age Sex Outcome Treatment
    1