BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 13606047 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00052
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    June 26, 2019
    Report Date
    June 26, 2019
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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, THE IMPLANT COMPLETELY SUBSIDED AND THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY TO UNDERGO AN ARTHROSURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2406247 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC CAR-10-US F082318002

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention