BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMET RESURFACING

    MDR report key: 2855951 · Received November 23, 2012

    Report

    Report Number
    9614209-2012-00059
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Report Date
    October 29, 2012
    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). DEVICE DETAILS, PT NOTES, X-RAYS AND EXPLANT REQUESTED.

    Description of Event or Problem · 1

    CORMET REVISION (PRIMARY IN 2006).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization