BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL TIBIA - TIBIAL STEM

    MDR report key: 9621730 · Received January 23, 2020

    Report

    Report Number
    3004105610-2020-00013
    Event Type
    Injury
    Date Received
    January 23, 2020
    Date of Event
    October 14, 2019
    Report Date
    January 23, 2020
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS SIMILAR TO A DEVICE APPROVED FOR COMPASSIONATE USE IN THE UNITED STATES. AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT WILL HAVE A REVISION DUE TO A BROKEN ROTATING HINGE. FEMORAL AND TIBIAL SHAFT COMPONENTS ARE STILL WELL FIXED. THE PATIENT HAS A GROSS CLINICAL INSTABILITY AND IS UNABLE TO WALK WITHOUT CRUTCHES AND LOWER LIMB ORTHOSIS. SO WE NEED TO CHANGE ONLY THE ROTATING HINGE. UPDATE 07JAN2020 - LOOSENING OF THE TIBIAL STEM (PROXIMAL TIBIA PIN 3179) HAS BEEN IDENTIFIED DURING X-RAY REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83077 PROXIMAL TIBIA - TIBIAL STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE PIN 3179

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R