BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 11664625 · Received April 14, 2021

    Report

    Report Number
    3009351194-2021-00100
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 17, 2021
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 "IT HAS A HIGH FAILURE RATE. I LIMPED AND SUFFERED PAIN FOR 2 YRS WITH CARTIVA. I HELD ON TO TRY TO MAKE IT WORK. I'M CURRENTLY RECOVERING FROM FUSION FROM A BADLY EFFED UP METATARSAL. I'M (B)(6) BIRK WEARER, RARELY HIGH HEELS FOR THOSE BLAMING ARTHRITIS ON SHOES. GOOGLE 1ST"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561379 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention