BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA SYNTHETIC CARTILIAGE IMPLANT

    MDR report key: 8865905 · Received August 5, 2019

    Report

    Report Number
    MW5088807
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    October 8, 2018
    Report Date
    August 1, 2019
    Manufacturer
    WRIGHT MEDICAL / CARTIVA, INC.
    Product Code
    PNW
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON OCTOBER 8TH I HAD SURGERY TO IMPLANT CARTIVA TO CORRECT HALLUX RIGIDUS IN RIGHT BIG TOE. THE IMPLANT FAILED AND SANK INTO THE BONE. THIS REQUIRED REMOVAL AND A SUBSEQUENT FUSION SURGERY. THIS PUT ME OUT FOR MONTHS, UNABLE TO WALK OR DRIVE BECAUSE IT WAS ON MY RIGHT FOOT. IT ALSO MEANT HAVING TO PAY FOR SURGERY TWICE. REQUIRED SECOND SURGERY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656921 CARTIVA SYNTHETIC CARTILIAGE IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW WRIGHT MEDICAL / CARTIVA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R| S