BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET RESURFACING

    MDR report key: 3131082 · Received May 22, 2013

    Report

    Report Number
    9614209-2013-00017
    Date Received
    May 22, 2013
    Date of Event
    December 16, 2011
    Manufacturer
    CORIN LTD.
    Product Code
    NXT
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT NOTES, MEDICAL HISTORY, EXPLANT, X-RAYS TO BE REQUESTED SO INCIDENT CAN BE INVESTIGATED.

    Description of Event or Problem · 1

    CORMET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227175 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING NXT CORIN LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention