BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 11684926 · Received April 19, 2021

    Report

    Report Number
    3009351194-2021-00101
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    August 15, 2019
    Report Date
    March 22, 2021
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE RIGHT BIG TOE TO TREAT HALLUX RIGIDUS. ALLEGEDLY, AFTER 4 MONTHS THE PATIENT WAS TOLD THAT THE IMPLANT HAD FAILED AND THE PATIENT WOULD NEED TO UNDERGO A REVISION SURGERY. THE PATIENT WAS IN EXCRUCIATING PAIN AND UNDERWENT A REVISION TO REMOVE THE IMPLANT AND AN ALTERNATE PROCEDURE TO TREAT THE HALLUX RIGIDUS. DURING THE REVISION IT WAS DISCOVERED THAT THE IMPLANT RECEDED INTO THE BONE. THE PATIENT REPORTED THAT FOLLOWING THE ORIGINAL PROCEDURE SHE WAS NOT ABLE TO PARTICIPATE IN NORMAL OUTDOOR ACTIVITIES NOR WAS SHE ABLE TO EXERCISE. MOST OF THE TIME WAS SPENT ICING AND RESTING TO MITIGATE THE TOE PAIN. THE PATIENT ALSO REPORTS HAVING DIFFICULTY SLEEPING AND BECOMING EXCESSIVELY NERVOUS AND ANXIOUS. COULD NOT DO TYPICAL CHORES AROUND THE HOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585379 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention