BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET RESURFACING

    MDR report key: 4009975 · Received April 16, 2014

    Report

    Report Number
    9614209-2014-00028
    Date Received
    April 16, 2014
    Date of Event
    January 8, 2013
    Report Date
    April 14, 2014
    Manufacturer
    CORIN MEDICAL, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. DEVICE DETAILS, PT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING 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 AFTER 6 YEARS 2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233708 CORMET RESURFACING METAL ON METAL RE-SURFACING NXT CORIN MEDICAL, LTD. 179.250B KCIO

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR LOT JUUP| ASSOCIATED CORMET RESURFACING HEAD 179.044,