BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 11664502 · Received April 14, 2021

    Report

    Report Number
    3009351194-2021-00099
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    September 29, 2020
    Report Date
    March 17, 2021
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON A POST ON SOCIAL MEDIA "THAT THE IMPLANT LASTED ALL OF 4 MONTHS BEFORE IT HAD TO BE REMOVED. A LOT OF UNNECESSARY PAIN AND EXPENSE. IMPLANT COLLAPSED INTO HOLE DRILLED FOR POST. 2ND SURGEON WHO REMOVED IT, FILLED THE HOLE WITH BONE GRAFT, FUSED JOINT"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563032 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention