BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 13606315 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00080
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    July 17, 2019
    Report Date
    July 17, 2019
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    MEDWATCH REPORT RECEIVED STATED IN EVENT DESCRIPTION: " I HAD CARTIVA IMPLANT ON (8)(6) 2019 FOR BIG TOE ARTHRITIS (HALLUX RIGIDUS). IN ADDITION TO THE PAIN IN MY TOE I NOW HAVE PAIN ON THE BALL OF MY FOOT. VISITED ORTHOPEDIC SURGEON YESTERDAY (B)(6) 2019 (6 MONTHS F/U). DR DID AN X-RAY ON BIG TOE AND OCCLUDED THAT THE CARTIVA IMPLANT FAILED." REFER TO MEDWATCH REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407355 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability