BEUDAMED
    FDA Adverse Event Other Summary report: N

    NXT METAL ON METAL RE-SURFACING

    MDR report key: 3596358 · Received January 13, 2014

    Report

    Report Number
    9614209-2013-00133
    Event Type
    Other
    Date Received
    January 13, 2014
    Date of Event
    December 5, 2012
    Report Date
    November 11, 2013
    Manufacturer
    CORIN LTD
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CORMET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33501 NXT METAL ON METAL RE-SURFACING CORMET RESURFACING NXT CORIN LTD S179.254B

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention ASSOCIATED CORMET HEAD, PRODUCT CODE 179.048