BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3171803 · Received June 17, 2013

    Report

    Report Number
    3005477969-2013-00243
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 9, 2012
    Report Date
    September 20, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ELEVATED METAL ION LEVELS AND A POSSIBLE SOFT TISSUE REACTION. A SQUEAKING AND CLICKING SENSATION WAS REPORTED FROM (B)(6) 2008. FROM (B)(4) 2008 A 'RUBBING / GRATING SENSATION' WAS REPORTED AS HAVING OCCURRED EVERY 7 TO 8 WEEKS AND LASTING FOR 4 TO 7 DAYS. A 2 TO 3 MONTH HISTORY OF PAIN REPORTED (B)(6) 2011 DOWN THE PATIENT'S LEG AND RIGHT SIDE. NO PAIN IN LEFT HIP REPORTED6

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273466 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 50520

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R FEMORAL HEAD, PART # 121146, LOT # 51161