BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 13606228 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00062
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    September 5, 2019
    Report Date
    September 6, 2019
    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 · 0

    NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. ON (B)(6), 2020 STRYKER TRAUMA AND EXTREMITIES ACQUIRED CARTIVA, WRIGHT MEDICAL, TORNIER INC. AND TORNIER SAS. AN EFFORT WAS MADE TO ALIGN THE ACQUIRED ENTITY COMPLAINT FILES WITH STRYKER'S POLICIES AND PROCEDURES. STRYKER HAS PERFORMED RETROSPECTIVE REVIEW OF COMPLAINTS AND THE REPORTABILITY DECISION WAS REVISED TO REPORT THIS INCIDENT UNDER THE MDR/VIGILANCE PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE. ALLEGEDLY, VIA MEDWATCH (B)(4), "I HAD A CARTIVA IMPLANT (MADE BY WRIGHT MEDICAL) SURGICALLY INSERTED INTO MY RIGHT BIG TOE ON (B)(6) 2018. IT WAS TOUTED TO BE AN EFFECTIVE TREATMENT FOR HALUX-RIGIDUS - BASICALLY ARTHRITIS OF THE BIG TOE. SINCE THE SURGERY WAS PERFORMED, THE PAIN HAS ONLY GOTIEN WORSE. I CAN BARELY WALK WITHOUT EXTREME DISCOMFORT IN MOST SHOES. A SUBSEQUENT MRI HAS REVEALED THAT THE IMPLANT HAS CREATED (IN THE SURGEON'S WORDS) A STRESS REACTION IN THE BONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680585 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention