BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 17159846 · Received June 19, 2023

    Report

    Report Number
    1038671-2023-01399
    Event Type
    Injury
    Date Received
    June 19, 2023
    Date of Event
    May 20, 2023
    Report Date
    April 7, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862086389
    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 INVESTIGATION. D10: A180830 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM. A311872 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. A227692 320-15-04 - RS GLENOID PLATE POST AUG, 8 DEG, RIGHT. A261875 320-15-05 - EQ REV LOCKING SCREW. A230032 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S374723 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. A172477 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S287597 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. S392607 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0. A290051 321-52-10 - 3.2MM K-WIRE, THD, SHORT 2 K-WIRES PER PACK. A287545 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE. A295178 531-78-20 - SHOULDR GPS HEX PINS KIT. 2030922064 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT DEVELOPED A PROSTHETIC JOINT INFECTION AND WAS REVISED ON (B)(6) 2023. EVERYTHING WAS REMOVED TO TREAT THE INFECTION. 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
    415489 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 320-01-38 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1