BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET METAL ON METAL HIP RESURFACING

    MDR report key: 2492797 · Received March 14, 2012

    Report

    Report Number
    9614209-2012-00002
    Date Received
    March 14, 2012
    Date of Event
    May 1, 2009
    Report Date
    December 16, 2011
    Manufacturer
    CORIN LTD.
    Product Code
    NXT
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA COMPLAINT (B)(4).

    Description of Event or Problem · 1

    REVISION AFTER 1 YEAR FOLLOWING ANTERIOR DISLOCATION. (NOTIFICATION 2 1/2 YEARS AFTER EVENT).

    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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R