BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3142114 · Received June 3, 2013

    Report

    Report Number
    3005477969-2013-00223
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    July 13, 2009
    Report Date
    June 3, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT REVISIONS REFERRED TO ABOVE ARE TO BE SUBMITTED VIA SEPARATE MDRS 3005477969-2013-00224 AND 00225.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. THE DEVICES WERE IMPLANTED IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244148 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD, PART AND LOT# UNKNOWN