BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3251433 · Received July 29, 2013

    Report

    Report Number
    3005477969-2013-00315
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 24, 2013
    Report Date
    March 10, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ELEVATED METAL ION LEVELS. THE DEVICES WERE IMPLANTED IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354202 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R HEMI HEAD, # 74122538, LOT # UNKNOWN| MODULAR SLEEVE # 74222200, LOT # UNKNOWN| FEMORAL STEM, PART AND LOT # UNKNOWN| MODULAR SLEEVE, # 74222200, LOT # 11040| HEMI HEAD, # 74122538, LOT # 10480