BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEO KNEE XC

    MDR report key: 19762084 · Received July 17, 2024

    Report

    Report Number
    3003764610-2024-00005
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    October 20, 2023
    Report Date
    July 17, 2024
    Manufacturer
    OSSUR HF
    Product Code
    ISW
    UDI-DI
    05690977467873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE KNEE WAS MANUFACTURED IN APRIL 2016 AND HAD BEEN IN THE FIELD FOR OVER 7 YEARS WHEN THE INJURY OCCURRED. THE USER REPORTED THAT THE DEVICE DID NOT PROVIDE FLEXION RESISTANCE FROM 0-5°. THE LIKELY REASON FOR THE USER EXPERIENCING THE RESISTANCE ISSUE IS THE AGE OF THE ACTUATOR, WHICH WAS INSTALLED ON 2021-01-04 AND WAS THEREFORE ALMOST 3 YEARS OLD. IT IS LIKELY THAT THERE WAS PLAY IN THE UNIT WHICH RESULTED IN THE USER NOT FEELING ANY RESISTANCE IN THE FIRST FEW DEGREES OF FLEXION. THE PROBLEM IS RELATED TO WEAR AND TEAR DURING USE AND THERE IS NO EVIDENCE OF OTHER PROBLEMS OR MANUFACTURING DEFECTS.

    Description of Event or Problem · 0

    THE USER WAS WALKING THROUGH THE KITCHEN WHEN THE KNEE BUCKLED, IN AN ATTEMPT TO STEADY HIMSELF, THE USER GRABBED THE HANDLE OF A HOT SAUCEPAN ON A STOVE, SPILLING BOILING WATER ON HIS RIGHT ARM AND SUSTAINING A SCALD. HE LANDED ON HIS LEFT HAND, FRACTURING HIS WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145219 RHEO KNEE XC PROSTHETIC KNEE ISW OSSUR HF RKNXC230 05690977467873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other