BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM

    MDR report key: 19728971 · Received July 12, 2024

    Report

    Report Number
    1038671-2024-02374
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 25, 2024
    Report Date
    October 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862079329
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: A249934, 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE. A299972, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. A066431, 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG. A281406, 320-15-05 - EQ REV LOCKING SCREW. A255560, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. A209798, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. A257076, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S393422, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. A177144, 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0. A242276, 531-20-00 - SHLDR GPS RVRS DRILL KIT. A233072, 531-78-20 - SHOULDR GPS HEX PINS KIT. 06000522027, A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE REASON FOR THE REVISION WAS LIKELY DUE TO A PERIPROSTHETIC BONE FRACTURE. THE CAUSE OF THE BONE FRACTURE CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A PATIENT CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    APPROXIMATELY 1 YEAR 5 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT, THE PATIENT SUFFERED A PERIPROSTHETIC HUMERAL FRACTURE AND NEEDED PLATING AND STEM REPLACEMENT. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF THE DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348008 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 10885862079329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11.