BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 11602108 · Received April 1, 2021

    Report

    Report Number
    1038671-2021-00148
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 13, 2021
    Report Date
    April 1, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT DEVICE(S): 321-20-00, 6563877 - EQUINOXE REVERSE SHOULDER DRILL KIT. 320-15-05, 6746398 - EQ REV LOCKING SCREW. 320-15-03, 6600412 - RS GLENOID PLATE POST AUG, 8 DEG, LEFT. 320-01-38, 6578240 - EQUINOXE REVERSE 38MM GLENOSPHERE. 320-20-30, S130053 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 320-20-26, S200191 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 300-01-11, 6648953 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. 320-10-00, 6773121 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-20-00, 6642519 - EQ REVERSE TORQUE DEFINING SCREW KIT.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 6 WEEKS POSTOP THE INITIAL LEFT SHOULDER IMPLANT, DUE TO DISLOCATION. THE HEAD AND LINER ONLY WAS REVISED BECAUSE THE PATIENT WAS MEDICALLY UNSTABLE. THE DEVICES WILL NOT RETURN DUE TO FACILITY POLICY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499688 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-38-00 S121624 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R