BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 11884275 · Received May 26, 2021

    Report

    Report Number
    1038671-2021-00252
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 3, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED DISLOCATION AND REVISION ARE RELATED TO ANY DESIGN, MANUFACTURING, OR PATIENT RELATED ISSUES. THE CAUSE OF THE REVISION IS MOST LIKELY IS RELATED TO THE PATIENT¿S UNDERLYING CONDITION; HOWEVER, THAT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 320-15-01, 6815657 - EQ REV GLENOID PLATE. 320-20-38, S216201 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 320-20-34, S220186 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 320-20-34, S230797 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 320-01-42, 6504729 - EQUINOXE REVERSE 42MM GLENOSPHERE. 320-15-05, 6768179 - EQ REV LOCKING SCREW. 300-01-11, 6696062 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. 320-20-00, 6780178 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-10-00, 6763084 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 315-35-00, 6695195 - GLND KWIRE.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 1 MONTH POSTOPERATIVE THE RIGHT SHOULDER, THE (B)(6) Y/O MALE PATIENT SUBLUXED RIGHT SHOULDER POSTERIORLY. EXISTING LINER AND GLENOSPHERE REMOVED AND A CONSTRAINED LINER AND NEW GLENOSPHERE WERE IMPLANTED. DEVICES WERE DISPOSED BY FACILITY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783525 EQUINOXE REVERSE 42MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-42-00 S211096 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R