BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    MDR report key: 20485256 · Received October 18, 2024

    Report

    Report Number
    1038671-2024-04034
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 314-13-03 - EQUINOXE CAGE GLENOID MEDIUM, ALPHA 3898105; 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM 3901276; 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT 3918558; 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S 3937456; 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA) 3951292; 315-35-00 - GLND KWIRE 3953673; 315-35-00 - GLND KWIRE 3953685; 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT 3991776.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 9 YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT COMPLAINED OF PAIN AND THE SURGEON THOUGHT IT WAS A POSSIBLE INFECTION. THE SURGEON CHECKED THE STEM AND CONVERTED THE PATIENT FROM A HEMI TO A REVERSE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220023 EQUINOXE PRIMARY SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention