BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTROMOT K3 (KNEE)

    MDR report key: 468725 · Received June 23, 2003

    Report

    Report Number
    3003616068-2003-00001
    Event Type
    Other
    Date Received
    June 23, 2003
    Date of Event
    May 1, 2003
    Report Date
    June 23, 2003
    Manufacturer
    MEDIREHA GMBH
    Product Code
    BXB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM DISTRIBUTOR 8/14/2003: THE EVALUATION BY THE MFR CONFIRMED A LOOSE STRAIN RELIEF OF THE SPIRAL CABLE AND CABLE PLUG. THE DEVICE WILL BE REPAIRED WITH COMPLIANCE TO PRODUCT SPECIFICATIONS PRIOR TO RELEASE TO THE MARKET. A CORRECTIVE ACTION IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE PT'S K3 KNEE CONTINUOUS PASSIVE MOTION DEVICE FLEXED TO MAXIMUM SETTING WHILE USING THE DEVICE. THE REPORT INDICATES THE DEVICE WAS SET AT 20 DEGREES AND FLEXED TO MAXIMUM (BEYOND 85 DEGREES). THE PT STITCHES NEEDED TO BE REPLACED AFTER THE REPORTED INCIDENT OPENED THE INCISION FROM THE PREVIOUS KNEE SURGERY. THE PT RECOVERED AND NO ADDITIONAL MEDICAL TREATMENT IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTROMOT K3 (KNEE) CONTINUOUS PASSIVE MOTION BXB MEDIREHA GMBH 5300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other