BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 11957034 · Received June 7, 2021

    Report

    Report Number
    MW5101745
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    March 29, 2018
    Report Date
    June 3, 2021
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    PNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD SURGERY ON MY RIGHT GREAT TOE JOINT. CARTIVA DEVICE WAS IMPLANTED AND NEEDS TO BE REMOVED BECAUSE IT HAS FAILED CAUSING EXTREME PAIN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841301 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability