BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEO KNEE XC

    MDR report key: 19972545 · Received August 13, 2024

    Report

    Report Number
    3003764610-2024-00007
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 13, 2024
    Manufacturer
    OSSUR HF
    Product Code
    ISW
    UDI-DI
    05690977467804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT TRIPPED OVER PAVING STONES AND HURT HIS SHOULDER. PATIENT INDICATES THAT IT IS NOT CLEAR WHETHER THE TRIPPING WAS DUE TO KNEE MALFUNCTION OR IF HE JUST TRIPPED HIMSELF. AN MRI SCAN INDICATED THAT ROTATOR CUP OF PATIENT'S RIGHT SHOULDER IS TORN (UPPER TENDON TO LIFT ARM).

    Description of Event or Problem · 0

    PATIENT TRIPPED OVER PAVING STONES AND HURT HIS SHOULDER. PATIENT INDICATES THAT IT IS NOT CLEAR WHETHER THE TRIPPING WAS DUE TO KNEE MALFUNCTION OR IF HE JUST TRIPPED HIMSELF. AN MRI SCAN INDICATED THAT ROTATOR CUP OF PATIENT'S RIGHT SHOULDER IS TORN (UPPER TENDON TO LIFT ARM). THE SHOULDER WAS OPERATED AND PATIENT WILL FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683422 RHEO KNEE XC PROSTHETIC KNEE ISW OSSUR HF RKNXC0003 HF367058 05690977467804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention