BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET METAL ON METAL HIP RESURFACING

    MDR report key: 2434752 · Received January 24, 2012

    Report

    Report Number
    9614209-2012-00004
    Date Received
    January 24, 2012
    Date of Event
    November 4, 2011
    Report Date
    January 5, 2012
    Manufacturer
    CORIN LTD
    Product Code
    NXT
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA COMPLAINT (B)(4). REQUESTED X-RAYS AND EXPLANTS.

    Description of Event or Problem · 1

    REVISION AFTER 9 YEARS, FRACTURED FEMUR BELOW FEMORAL COMPONENT AFTER FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORMET METAL ON METAL HIP RESURFACING NXT PROST HIP SEMI-CONST MET/MET RESURF NXT CORIN LTD FAMB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R ASSOCIATED CUP DEVICE: CATALOG # 179.252B,| LOT # FAEW