BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORMET RESURFACING

    MDR report key: 3772333 · Received March 21, 2014

    Report

    Report Number
    9614209-2014-00010
    Event Type
    Other
    Date Received
    March 21, 2014
    Date of Event
    September 11, 2013
    Report Date
    March 21, 2014
    Manufacturer
    CORIN LTD
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. PATIENT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION WILL BE REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION.

    Description of Event or Problem · 1

    CORMET REVISION AFTER 4 YEARS DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170750 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING NXT CORIN LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R DATA ON ASSOCIATED DEVICES HAS NOT BEEN,| PROVIDED TO CORIN.