BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET RESURFACING

    MDR report key: 4009974 · Received April 17, 2014

    Report

    Report Number
    9614209-2014-00030
    Date Received
    April 17, 2014
    Date of Event
    September 26, 2009
    Report Date
    April 17, 2014
    Manufacturer
    CORIN LTD.
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT: DEVICE DETAILS, PATIENT 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.

    Description of Event or Problem · 1

    CORMET REVISION AFTER 5 YEARS DUE TO SEVERE PAIN AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235433 CORMET RESURFACING METAL ON METAL RE-SURFACING NXT CORIN LTD. 179.048 HEBR

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention