BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 4180407 · Received October 17, 2014

    Report

    Report Number
    3005477969-2014-00536
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    May 12, 2014
    Report Date
    December 1, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE CLIENT HAD A BIRMINGHAM HIP RESURFACING IN LATE 2005 COMPLICATED BY FEMORAL NECK FRACTURE APPROXIMATELY 2 YEARS LATER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLIENT IN (B)(6) SUSTAINED METAL TOXICITY AND A RIGHT HIP PSEUDO TUMOUR. IT IS UNCLEAR IF A REVISION SURGERY HAS BEEN PERFORMED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663069 BHR ACETLR CUP HAP 50MM W/ IMPTR NXT SMITH & NEPHEW ORTHOPAEDICS LTD 74120150 36157

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RESURFACING FEMORAL HEAD 42MM: 74121142, LOT 37263