BEUDAMED
    FDA Adverse Event Other Summary report: N

    NXT METAL ON METAL RE-SURFACING

    MDR report key: 3593266 · Received January 14, 2014

    Report

    Report Number
    9614209-2014-00001
    Event Type
    Other
    Date Received
    January 14, 2014
    Report Date
    December 16, 2013
    Manufacturer
    CORIN LTD.
    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.

    Description of Event or Problem · 1

    CORMET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37687 NXT METAL ON METAL RE-SURFACING CORMET RESURFACING NXT CORIN LTD. 179.260B JSMY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASSOCIATED CORMET HEAD 179.052B: LOT CODE JRTR