BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3142117 · Received June 3, 2013

    Report

    Report Number
    3005477969-2013-00225
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    April 8, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO PRIOR REVISION SURGERIES REFERRED TO ABOVE WERE REPORTED VIA MDRS 3005477969-2013-00223 AND 00224.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244149 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 50636

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MODULAR HEAD, PART # 74222158, LOT # 9748| MODULAR SLEEVE, # 74222300, LOT # 07FW12485