BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTIVA SCI IMPLANT FOR MTP

    MDR report key: 13606431 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00046
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    May 20, 2019
    Report Date
    June 4, 2019
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: MW5086840.

    Description of Event or Problem · 0

    MEDWATCH REPORT RECEIVED STATED IN EVENT DESCRIPTION: "I HAD A CARTIVA IMPLANT ON MY TOE. THE PAIN IS PROGRESSIVELY GETTING WORSE SINCE I HAD THE SURGERY. IT'S HARD FOR ME TO WALK OR EXERCISE. I HAVE GAINED WEIGHT. I WAS TOLD MY SURGERY WAS A FAILURE BY MY DR. I AM REFUSING TO HAVE ANOTHER SURGERY AT THIS TIME I CAN'T AFFORD TO TAKE TIME OFF FROM WORK OR ANOTHER SURGERY. THE DR TOLD ME I WOULD BE CONSIDERED A SUCCESS BECAUSE L'M NOT GETTING ANOTHER SURGERY. THIS IS MISLEADING AND VERY DISAPPOINTING THAT THE FDA WOULD BACK THIS PRODUCT. IT SHOULD BE REMOVED FROM THE MARKET. I HAVE DEVELOPED PAIN IN MY KNEE AND HIP BEING THAT I AM TRYING TO KEEP WEIGHT OFF MY BIG TOE WHEN I WALK."REFER TO MEDWATCH MW5086840.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229827 CARTIVA SCI IMPLANT FOR MTP METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PROSTHESIS, PNW CARTIVA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability