BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 4216346 · Received October 23, 2014

    Report

    Report Number
    9614209-2014-00090
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    June 25, 2013
    Report Date
    October 24, 2014
    Manufacturer
    CORIN MEDICAL, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH INVESTIGATION. DEVICE MANUFACTURING RECORDS WILL BE REVIEWED. 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 5 YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677365 CORMET HIP RESURFACING PROTHESIS NXT CORIN MEDICAL, LTD. 179.246B KBFW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASSOCIATE CORMET RESURFACIG HEAD 179.040B,| LOT KTZN