BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOSTIM

    MDR report key: 24229066 · Received February 2, 2026

    Report

    Report Number
    MW5183088
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    October 17, 2025
    Report Date
    January 29, 2026
    Manufacturer
    ORTHOFIX US LLC.
    Product Code
    LOF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER'S SURGEON RECOMMENDED THIS STIMULATOR DEVICE DUE TO HER HIP BONE NOT HEALING AS QUICKLY AS WANTED. SHE USED THIS DEVICE FOR 3 DAYS, 3 HOURS PER DAY. REPORTER STATES BEING IN A WORSE CONDITION THAN WHEN SHE STARTED USING THE DEVICE. SHE HAD MORE PAIN, HAD TO START GOING TO PHYSICAL THERAPY, AND STARTED USING A CANE. REPORTER STATES HER PAIN BEING UNBEARABLE AND THE SURGEON TELLING HER TO DISCONTINUE USING THE DEVICE. SHE ALSO STATES THAT THE DEVICE BURST A CYST ON HER BACK AND LEFT HER HEAVILY BRUISED. REPORTER STATES FINDING ONLINE THAT THE MANUFACTURER HAS SEVERAL CLASS ACTION LAWSUITS AGAINST THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290617 PHYSIOSTIM STIMULATOR, BONE GROWTH, NON-INVASIVE LOF ORTHOFIX US LLC. 655315-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Other