BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET RESURFACING

    MDR report key: 4101598 · Received August 27, 2014

    Report

    Report Number
    9614209-2014-00071
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    January 31, 2013
    Report Date
    August 26, 2014
    Manufacturer
    CORIN 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, 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 CANNOT BE REVIEWED AT THIS TIME FOR EITHER THE FEMORAL HEAD OR THE ACETABULAR CUP COMPONENTS AS NO DEVICE DETAILS HAVE BEEN PROVIDED. 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

    REVISION OF AN UNSPECIFIED CORMET IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522514 CORMET RESURFACING METAL ON METAL RE-SURFACING NXT CORIN LTD. DATA NOT PROVIDED DATA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention DATA NOT PROVIDED