BEUDAMED
    FDA Adverse Event Summary report: N

    CORMET RESURFACING

    MDR report key: 3418785 · Received October 10, 2013

    Report

    Report Number
    9614209-2013-00093
    Date Received
    October 10, 2013
    Date of Event
    November 30, 2010
    Report Date
    January 14, 2013
    Manufacturer
    CORIN LDT
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA (B)(4). PATIENT NOTES, MEDICAL HISTORY, DEVICE DETAILS, EXPLANT, X-RAYS TO BE REQUESTED SO INCIDENT CAN BE INVESTIGATED. DEVICE HISTORY RECORDS TO BE REVIEWED. PLEASE NOTE: THIS ISSUE WAS REPORTED DUE TO CORMET CUP, BUT THIS WAS COUPLED WITH A THR WITH A LARGE DIAMETER MOM HEAD WHICH IS NOT CLEARED FOR SALE IN THE USA (INCIDENT OCCURRED OUTSIDE OF USA).

    Description of Event or Problem · 1

    CORMET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518461 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING NXT CORIN LDT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention