BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 13606088 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00061
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    June 4, 2018
    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 IMPLANT OF LEFT GREAT TOE (8)(6) 2018. IMPLANT RECEDED INTO BONE AND HAD SEVERAL CORTISONE SHOTS TO HELP RELIEVE PAIN OVER SEVERAL MONTHS ((B) (6) 2018, (8)(6) 2018, (8)(6) 2018). CT SCAN (B)(6) 2018 REVEALED BONE ON BONE ONCE AGAIN. I WAS IN CONSTANT PAIN AND WAS REFERRED TO ANOTHER DOCTOR FOR REMOVAL AND ADDITIONAL SURGERY. REMOVAL, BONE GRAFT FROM LEFT KNEE AND INTERPOSITIONAL ARTHROPLASTY PERFORMED "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399647 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention