BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM

    MDR report key: 17159823 · Received June 19, 2023

    Report

    Report Number
    1038671-2023-01396
    Event Type
    Injury
    Date Received
    June 19, 2023
    Date of Event
    January 25, 2023
    Report Date
    December 3, 2025
    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: EQUINOXE REVERSE 36MM HUMERAL LINER +0 320-36-00 A091112; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 320-10-00 A227904; GLENOID PLATE 320-15-01 A213921; EQ REV LOCKING SCREW 320-15-05 A145777; EQ REVERSE TORQUE DEFINING SCREW KIT 320-20-00 A140513; EQUINOXE REVERSE 36MM GLENOSPHERE 320-01-36 A053732.

    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 SURGICAL FRACTURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT WAS REVISED TO A FRACTURE PLATFORM STEM ON (B)(6) 2023 DUE TO A BONE FRACTURE AND STEM DISLOCATION. 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
    710336 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 300-01-13 10885862079329

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R