BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM GLENOSPHERE

    MDR report key: 17330010 · Received July 14, 2023

    Report

    Report Number
    1038671-2023-01664
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 28, 2023
    Report Date
    February 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862086389
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 4113807 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. 4277010 315-35-00 - GLND KWIRE. 4279690 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 4279907 320-15-01 - EQ REV GLENOID PLATE. 4257768 320-15-05 - EQ REV LOCKING SCREW. 4248153 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. 4126613 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. 4277156 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. 4252666 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 4129894 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 2233357 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM. 4246059 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0. 4332952 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2016. THE PATIENT PRESENTED WITH SWELLING AND PAIN IN THEIR RIGHT SHOULDER. THE SURGEON OPENED THE SHOULDER AND FOUND FRANK PUS IN JOINT. THE GLENOSPHERE, TRAY AND LINER WERE REMOVED, BUT COULD NOT GET THE STEM OUT. DECISION TO PERFORM DAIR PROCEDURE MADE. 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
    693231 EQUINOXE REVERSE 38MM GLENOSPHERE PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 320-01-38 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SEE H10