BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTIVA SCI IMPLANT FOR MTP

    MDR report key: 13606263 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00045
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    May 19, 2019
    Report Date
    June 6, 2019
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS REGARDING MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY OR MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTION OR IS RELATED TO A DEATH OR INJURY. MEDWATCH SUBMITTED: MW5086828.

    Description of Event or Problem · 0

    MEDWATCH REPORT RECEIVED STATED IN EVENT DESCRIPTION: "RECEIVED A CARTIVA IMPLANT LEFT GREAT TOE. IT FAILED ALMOST IMMEDIATELY. I LOST THE ABILITY TO MOVE MY TOE INCREASED PAIN CONSTANT ANGUISH. A FEW WEEKS AFTER RECEIVING A CARTIVA IMPLANT A PHYSICAL THERAPIST SAID MY TOE WAS FUSED AND PHYSICAL THERAPY WOULDN'T HELP. I NOW HAVE BONE ON BONE PAIN. MY PAIN ABILITY TO MOVE MY TOE JOINT MY MOBILITY AND MY QUALITY OF LIFE ARE SIGNIFICANTLY WORSE AFTER GETTING CARTIVA. I'M MISERABLE. BASED ON MY RESEARCH THERE IS A DISCREPANCY IN CARTIVA'S CLINICAL STUDY DATA (GLOWING AMAZING REVIEWS) AND THE AMOUNT OF CARTIVA COMPLAINTS AFTER BEING FDA APPROVED. THIS PRODUCT SHOULD BE TAKEN OFF THE MARKET. L'D LIKE TO FILE A FORMAL COMPLAINT ABOUT THE CARTIVA IMPLANT. ."REFER TO MEDWATCH MW5086828.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436878 CARTIVA SCI IMPLANT FOR MTP METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PROSTHESIS, PNW CARTIVA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability