BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT 10 MM

    MDR report key: 7037482 · Received November 15, 2017

    Report

    Report Number
    MW5073385
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    April 6, 2017
    Report Date
    October 20, 2017
    Manufacturer
    CARTIVA, INC.
    Product Code
    PNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A SURGERY FOR HALLUX RIGIDUS OF MY BIG LEFT TOE WITH A CARTIVA IMPLANT PUT IN MTP JOINT. IT WAS A FAILED SURGERY AND THE IMPLANT IS NOT IN PLACE. X-RAYS PROVED THE IMPLANT SUBSIDED AND ISN'T IN THE PROPER PLACE, LEAVING ME WITH BONE ON BONE. THEN I DEVELOPED CRPS. THE DAY OF THE SURGERY WAS (B)(6) 2017. I COULD NOT ACCUMULATE FROM DAY ONE. IT WAS SUPPOSE TO BE EASY BACK TO WORK IN 2 WEEKS. WELL, NOT MY STORY I COULDN'T WALK WITHOUT CRUTCHES - WALKER, SEVERE PAIN, REDNESS, SWELLING. MY SURGEON STATED IT WAS A FAILED SURGERY ABOUT 7 WEEKS AFTER, I HAD RETROGRESSED AND STILL IN SEVERE PAIN. THE X-RAYS CONFIRMED THE CARTIVA IMPLANT WASN'T IN THE PACER. IT WAS SUPPOSE TO BE LEAVING ME WITH BONE ON BONE AND THE CONDITION CHRONIC REGIONAL PAIN SYNDROME (CRPS). THIS CONDITION LEAVES ME WITH NO OPTION FOR SURGERY TO CORRECT THIS ISSUE. THE RISK IS THE CRPS SPREADING TO OTHER PARTS OF MY BODY (NERVE DAMAGE). THE CARTIVA REMAINS IN MY FOOT JUST NOT IN PLACE. DEVELOPED HYPERTENSION AFTER SURGERY, GAD, DEVELOPED CRPS AFTER THE SURGERY. PTSD AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811187 CARTIVA IMPLANT 10 MM PROSTHESIS, METATORS OPHALANGEAL JOINT CARTRIDGE REPLACEMENT IMPLANT 10MM PNW CARTIVA, INC. F010517002

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability