BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET RESURFACING

    MDR report key: 3113602 · Received May 10, 2013

    Report

    Report Number
    9614209-2013-00015
    Date Received
    May 10, 2013
    Date of Event
    March 2, 2009
    Report Date
    April 2, 2013
    Manufacturer
    CORIN, LTD.
    Product Code
    NXT
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). X-RAYS SHOW THE ACETABULAR COMPONENT TO BE EXCESSIVELY ANTEVERTED. BATCH MFG RECORDS TO BE REVIEWED.

    Description of Event or Problem · 1

    CORMET REVISION DUE TO IMPINGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207438 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING NXT CORIN, LTD. 179.250B KEWK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization LOT JXNS| ASSOCIATED CORMET RESURFACING HEAD CODE 179.044,