BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET RESURFACING

    MDR report key: 3251835 · Received July 24, 2013

    Report

    Report Number
    9614209-2013-00032
    Date Received
    July 24, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 17, 2013
    Manufacturer
    CORIN, LTD.
    Product Code
    NXT
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA (B)(4). PT NOTES, MEDICAL HISTORY, DEVICE DETAILS, X-RAYS TO BE REQUESTED SO INCIDENT CAN BE INVESTIGATED. DEVICE HISTORY RECORDS TO BE REVIEWED.

    Description of Event or Problem · 1

    PT RECEIVED A LETTER STATING THAT THERE WAS A SAFETY CONCERN REGARDING A COMPONENT OF HER IMPLANT. SHE CONSEQUENTLY SAID THAT SINCE THE IMPLANTATION OF THE IMPLANT, SHE HAS BEEN EXPERIENCING CHRONIC GROIN PAIN, LIMPING, METAL TASTE IN MOUTH, SWELLING IN LEG AND HIP, NUMBNESS IN HER FEET, LIMITED RANGE OF MOVEMENT AND HIGH BLOOD PRESSURE. SHE HAS ALSO REPORTED THAT SHE FEELS HER HIP POPPING AND MOVING, AND IT MAKES A NOISE WHEN SHE MOVES. SHE ALSO SAYS SHE HAS BONE AND TISSUE DETERIORATION. IMPLANT HAS NOT YET BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344651 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING NXT CORIN, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention