BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 13606270 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00060
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    August 26, 2019
    Report Date
    August 26, 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), "CARTIVA SCI (SURGICAL CARTILAGE IMPLANT) OF THE FIRST MPJ DUE TO HALLIUX RIGIDUS WAS SURGICALLY PLACED IN (B)(6) 2018 DUE TO A LENGTHY AND PAINFUL IMMOBILITY OF THE TOE. RECOVERY WAS DIFFICULT AS I AM A TEACHER. I LITERALLY WHEELED MYSELF IN A CHAIR ON WHEELS FOR OVER 3 MONTHS UP AND DOWN THE SCHOOL HALLWAYS. I ATIENDED PHYSICAL THERAPY FOR MONTHS THE TOE JOINT NEVER GAINED MOTION BACK AND THE PAIN IS ALMOST EQUAL TO WHAT IT WAS PRIOR TO SURGERY. ANKLE, HEEL, KNEE, HIP ISSUE. (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436883 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention