BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINEX CONNECT

    MDR report key: 21111670 · Received January 8, 2025

    Report

    Report Number
    MW5164465
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 8, 2025
    Manufacturer
    KINEX MEDICAL COMPANY
    Product Code
    BXB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER STATES HER HUSBAND (PATIENT) HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2024 AND WHEN HE WAS DISCHARGED HOME, HE BEGAN USING KINEX CONNECT. ON (B)(6) 2025 THE REPORTER CONNECTED THE DEVICE TO THE PATIENT AND SET THE DEVICE AT 80 POINTS. THE REPORTER LEFT THE ROOM AND A FEW MOMENTS LATER SHE HEARD HER HUSBAND YELLING HER NAME. WHEN THE REPORTER ENTERED THE ROOM, SHE STATES SHE SAW THE PATIENT'S KNEE BENT ALL THE WAY BACK. THE PATIENT WAS EXPERIENCING SEVERE PAIN AND HAD DIFFICULTY WALKING. REPORTER DISCONNECTED THE DEVICE FROM THE PATIENT AND NOTED THE SETTING WAS AT 134 POINTS. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE AND HAS BEEN ADMITTED SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352430 KINEX CONNECT EXERCISER, POWERED BXB KINEX MEDICAL COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization