BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET RESURFACING

    MDR report key: 5766259 · Received June 17, 2014

    Report

    Report Number
    9614209-2014-00056
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 17, 2014
    Manufacturer
    CORIN LTD.
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. DEVICE DETAILS, PT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REPORTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MFG RECORDS TO BE REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA. HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    CORMET REVISION TO RIGHT HIP DUE TO PAIN AND ELEVATED CHROMIUM AND COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356924 CORMET RESURFACING METAL ON METAL RE-SURFACING NXT CORIN LTD. 179.254B NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1