BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET

    MDR report key: 2850892 · Received November 23, 2012

    Report

    Report Number
    9614209-2012-00053
    Date Received
    November 23, 2012
    Date of Event
    July 12, 2012
    Report Date
    October 1, 2012
    Manufacturer
    CORIN LTD.
    Product Code
    NXT
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA (B)(4).

    Description of Event or Problem · 1

    CORMET REVISION AFTER 2.5 YEARS DUE TO HIGH COBALT CHROME ION LEVEL IN BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORMET NXT METAL ON METAL RE-SURFACING NXT CORIN LTD. 179.254B NSQW

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization ASSOCIATED CORMET BICOATED HEAD: 480.048, LOT NFSH