BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTIVA

    MDR report key: 10028558 · Received May 5, 2020

    Report

    Report Number
    MW5094393
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    December 7, 2018
    Report Date
    May 3, 2020
    Manufacturer
    CARTIVA, INC.
    Product Code
    PNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SURGERY TO REMOVE FAILED DEVICE; SURGEON INSTALL THE CARTIVA DEVICE ON LEFT MTP JOINT. THE JOINT NEVER RECOVERED. THE PAIN NEVER DECREASED. HAD A RECENT X-RAY THAT SHOWED THE JOINT WAS BACK TO THE PRE-SURGERY STATE OF BONE-ON-BONE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486624 CARTIVA PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other