BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 4151555 · Received October 3, 2014

    Report

    Report Number
    9614209-2014-00086
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    May 13, 2014
    Report Date
    October 3, 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). DEVICE DETAILS, PATIENT MEDICAL HISTORY, 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.

    Description of Event or Problem · 1

    CORMET REVISION AFTER 8 YEARS 7 MONTHS DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618893 CORMET HIP RESURFACING SYSTEM NXT CORIN MEDICAL, LTD. 179.044 ISGQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASSOCIATED CORMET HEAD,| DEVICE DETAILS NO AVAILABLE.