BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3844719 · Received June 3, 2014

    Report

    Report Number
    3005477969-2014-00352
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    April 8, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SMITH & NEPHEW
    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

    SWELLING REVISION SURGERY PERFORMED DUE TO SWELLING OF RIGHT LEG AND SMALL FLUID POCKET IN RIGHT GROIN. PATIENT HAD FALLS IN LATE NOVEMBER/ EARLY (B)(6) 2011 AND (B)(6) 2012 (FELL BACKWARDS, TWISTED TO SAVE HIP) AND 2 MONTHS AFTER (B)(6) FALL DEVELOPED A PAINLESS SWELLING OF RIGHT LEG ALL OVER, WORSE AROUND THE CALF AND ANKLE OF RIGHT FOOT. DOPPLER CONFIRMED NO DVT. WHOLE BLOOD METAL ION TESTING DONE IN (B)(6) IN (B)(6) 2013: COBALT=5.1PPB, CHROMIUM=3.31PPB. ON EXAMINATION ON (B)(6) 2014, IT WAS NOTED THERE WAS SWELLING OF THE RIGHT LOWER LIMB, WORSE BELOW KNEE, REDNESS AND PITTING OEDEMA, AND A PALPABLE SWELLING FIRM AROUND 10CM WIDE. X-RAYS REVISED. REVISION SURGERY NOTED THERE WAS FLUID IN THE HIP JOINT AND THIS WAS SENT FOR CULTURE. THE SYNOVIUM WAS SLIGHTLY DISCOLOURED, POSSIBLY WITH METAL. THE BEARING LOOED PRISTINE, BUT WHEN THE FEMORAL HEAD WAS REMOVED THERE WAS CORROSION AT THE HEAD/NECK TAPER. X-RAYS TAKEN ON:(B)(6) 2008, PRE OP THR.(B)(6) 2014, PRE-OP REVISION.(B)(6) 2014, POST-OP REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324563 BHR ACETABULAR CUP NXT SMITH & NEPHEW 08DW16574 008

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R MODULAR SLEEVE, # 74222100, LOT # 08CW16013| MODULAR HEAD, # 74222150, LOT # 08EW17063 011