BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET RESURFACING

    MDR report key: 3060415 · Received April 11, 2013

    Report

    Report Number
    9614209-2013-00010
    Date Received
    April 11, 2013
    Date of Event
    June 1, 2010
    Report Date
    March 28, 2013
    Manufacturer
    CORIN LTD.
    Product Code
    NXT
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA (B)(4). PT NOTES, MEDICAL HISTORY, EXPLANT, X-RAYS TO BE REQUESTED SO INCIDENT CAN BE INVESTIGATES.

    Description of Event or Problem · 1

    CORMET REVISION DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156639 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING NXT CORIN LTD. UNK AT PRESENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention