BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET RESURFACING

    MDR report key: 3251834 · Received July 24, 2013

    Report

    Report Number
    9614209-2013-00033
    Date Received
    July 24, 2013
    Report Date
    July 18, 2013
    Manufacturer
    CORIN LTD.
    Product Code
    NXT
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA (B)(4). PT NOTES, MEDICAL HISTORY, DEVICE DETAILS, EXPLANT, X-RAYS TO BE REQUESTED SO INCIDENT CAN BE INVESTIGATED. DEVICE HISTORY RECORDS TO BE REVIEWED.

    Description of Event or Problem · 1

    CORMET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345346 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING NXT CORIN LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention