BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA SCI

    MDR report key: 7076476 · Received December 1, 2017

    Report

    Report Number
    3009351194-2017-00004
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    October 3, 2017
    Report Date
    December 1, 2017
    Manufacturer
    CARTIVA, INC.
    Product Code
    PNW
    UDI-DI
    00852897002038
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF IMPLANT, THE DRILL BIT WAS INSERTED AND THE CAVITY WAS NOT FULLY DRILLED DUE TO A SMALL AREA OF PATIENT BONE PREVENTING THE IMPLANT FROM SITTING PROPERLY. THE CAVITY WAS DRILLED ADDITIONALLY TO REMOVE ANY BONE THAT MIGHT REMAIN AND THE IMPLANT WAS SEATED PROUD. THE PATIENT UNDERWENT MANIPULATION OF THE OF THE TOE AND THE IMPLANT WAS NOTED TO BE PROUD AT THAT TIME ((B)(6) 2017). A CAPSULOTOMY AND RELEASE OF THE LATERAL LIGAMENTS WAS ALSO CARRIED OUT. AFTER REMOVAL OF THE CARTIVA DEVICE, THE TISSUE WAS NOTED TO BE WITH FIBROSIS AND INFLAMMATION. AT THAT TIME, THE DEVICE APPEARED TO HAVE SUNKEN INTO THE CAVITY AND WAS NO LONGER PROUD.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED ON 1 NOV 2017, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED SWELLING AND PAIN THAT DID NOT RESOLVE POST-OPERATIVE OF RECEIVING A 10 MM CARTIVA DEVICE FOR 1ST MTP JOINT OSTEOARTHRITIS. ACCORDING TO THE REPORT, THE PATIENT HAD A HISTORY OF OSTEOMYELITIS AND CHEILECTOMY IN THE SAME JOINT. THE CARTIVA IMPLANT AT APPROXIMATELY 4 MONTHS POST-OPERATIVE. THE SURGEON REPORTED THAT THERE DID NOT APPEAR TO BE ANY ACTIVE ISSUE OTHER THAN THE HALLUX RIGIDIS AT THE TIME OF REMOVAL. THERE WAS NO HOSPITALIZATION AND NO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856383 CARTIVA SCI CARTIVA SCI, PNW CARTIVA, INC. CAR-10 F042717002 00852897002038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention