BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 13606090 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00063
    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

    H6: 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), "RECEIVED A CARTIVA JOINT REPLACEMENT IMPLANT IN MY LEFT BIG TOE TO HELP RESOLVE HALLUX RIGIDUS. IN MORE THAN A YEAR POST-SURGERY, MY PAIN HAS INCREASED TO LEVELS WORSE THAN IT WAS BEFORE SURGERY, RECEIVED A SECOND OPINION FROM ANOTHER SURGEON WHO STATED THAT THE JOINT SPACE HAS DECREASED SIGNIFICANTLY AND SHE RECOMMENDS REMOVING THE CARTIVA IMPLANT AND REPLACING IT WITH A HEMICAP IMPLANT. SHE MENTIONED SHE SEES A LOT OF FAILED CARTIVA IMPLANTS. SURGERY TO REMOVE CARTIVA AND REPLACE IT WITH HEMICAP SCHEDULED FOR 2019."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399649 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention