BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORMET RESURFACING

    MDR report key: 3133677 · Received May 23, 2013

    Report

    Report Number
    9614209-2013-00019
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    June 16, 2011
    Report Date
    April 25, 2013
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    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, 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
    229521 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING LZO CORIN LTD 179.250B HCEU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASSOCAITED CORMET HEAD 179.044 LOT HLFP