BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REPLICATOR PLATE 4.5MM O/S

    MDR report key: 16016670 · Received December 20, 2022

    Report

    Report Number
    1038671-2022-01610
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    November 2, 2022
    Report Date
    February 20, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079398
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: 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 SHOULDER REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. IT IS KNOWN THAT PATIENT¿S AGE, WEIGHT, AND ACTIVITY LEVEL, WOULD CAUSE THE SURGEON TO EXPECT EARLY FAILURE OF THE SYSTEM. CONCOMITANT MEDICAL PRODUCTS: 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT 6912735, 310-03-47 - EQUINOXE, HUMERAL HEAD EXPANDED, 47MM (BETA) 4184470.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 9 MONTHS POST OP THE RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY OF THIS 69 Y/O MALE PATIENT WAS REVISED. THE PATIENT PRESENTED WITH GLENOID EROSION FROM A HEMI IN PLACE AND WAS REVISED TO EXACTECH REVERSE HUMERAL COMPONENTS AND OTHER MANUFACTURES GLENOID COMPONENTS. THERE WERE NO REPORTED ISSUES WITH THE REVISION PROCEDURE. THE PATIENT WAS DEEMED STABLE AFTER THE PROCEDURE. THE DEVISES WILL NOT BE RETURNED DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588517 EQUINOXE REPLICATOR PLATE 4.5MM O/S PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 300-10-45 UNK 10885862079398

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention