BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTIVA SCI IMPLANT FOR MTP

    MDR report key: 13606580 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00085
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    November 28, 2017
    Report Date
    May 8, 2018
    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

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. 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

    I HAVE A FAILED CARTIVA IMPLANT AND AM NOW CURRENTLY LOOKING FOR OTHER OPTIONS. I AM TRYING TO FIGURE OUT WHY IT FAILED, AND I AM STILL IN MORE PAIN THAN BEFORE. I HAD MY SURGERY ON (B)(6) 2017. INFORMATION RECEIVED FROM A PATIENT THRU CARTIVA WEBSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399679 CARTIVA SCI IMPLANT FOR MTP METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PROSTHESIS, PNW CARTIVA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability