BEUDAMED
    FDA Adverse Event Summary report: N

    BIRMINGHAM HIP RESURFACING SYSTEM

    MDR report key: 2980698 · Received February 22, 2013

    Report

    Report Number
    MW5029127
    Date Received
    February 22, 2013
    Date of Event
    June 6, 2011
    Report Date
    February 14, 2013
    Manufacturer
    SMITH & NEPHEW
    Product Code
    KXA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ELEVATED COBALT AND CHROMIUM LEVELS. EYE PROBLEMS AND HEARING DIFFICULTY, LACK OF ENERGY. LYMPH NODE AT LEFT GROIN AT SITE OF HIP REPLACEMENT. FAILURE OF SMITH AND NEPHEW TO REGULARLY MONITOR AND PROVIDE FOLLOW-UP EXAMINATION AND TESTING, INCLUDING THE PAYMENT OF THE COSTS ASSOCIATED WITH METAL ON METAL MEASUREMENTS AND ASSESSMENTS OF RENAL FUNCTION, REQUIRED PROCEDURES AND EXAMINATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77995 BIRMINGHAM HIP RESURFACING SYSTEM METAL ON METAL HIP REPLACEMENT KXA SMITH & NEPHEW 74121150
    77996 BIRMINGHAM HIP RESURFACING SYSTEM METAL ON METAL HIP REPLACEMENT KXA SMITH & NEPHEW 74120156

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| O