BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP PROSTHESIS COBALT + CHROMIUM METAL ON METAL

    MDR report key: 4109257 · Received September 7, 2014

    Report

    Report Number
    MW5038256
    Event Type
    Injury
    Date Received
    September 7, 2014
    Date of Event
    July 1, 2014
    Report Date
    September 7, 2014
    Manufacturer
    WRIGHT MEDICAL TECH. INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2005, I HAD A RIGHT HIP REPLACEMENT WITH A PROSTHESIS MADE BY WRIGHT MEDICAL TECHNOLOGY, INC. (IT WAS A COBALT CHROMIUM METAL ON METAL PROSTHESIS.) MONTHS AFTER HAVING THE HIP REPLACEMENT, I EXPERIENCED GREAT DISCOMFORT AND DIFFICULTY WALKING. ON TWO DIFFERENT OCCASIONS, MY SURGEON PRONOUNCED THAT THERE WAS NO PROBLEM WITH MY NEW HIP. ON THE SECOND VISIT OF MY COMPLAINTS, MY SURGEON REFERRED ME TO A DIFFERENT ORTHOPEDIST. THE NEW DOCTOR EXPLAINED THAT IN SOME PATIENTS THERE COULD BE A SIGNIFICANT BUILD UP OF METAL IONS. HE SUBSEQUENTLY DRAINED THE HIP AND THE PROBLEM WAS ALLEVIATED. MONTHS LATER, THE SAME PROBLEM OCCURRED AND THE HIP WAS DRAINED AGAIN. IN (B)(6) 2014 WHILE WALKING, NOT STUMBLING OR LOSING MY BALANCE; I FELT AN EXPLODING SENSATION IN MY HIP. I IMMEDIATELY CRUMBLED TO THE GROUND. AT THAT TIME I WAS VISITING MY OLDEST SON IN (B)(6). I WAS TAKEN TO A NEARBY HOSPITAL AND TOLD HOURS LATER THAT MY PROSTHESIS HAD BROKEN. SUBSEQUENTLY, I SPENT 10 DAYS IN THE HOSPITAL AND UNDERWENT COMPLETE REVISION SURGERY. DURING THIS OPERATION BY DR (B)(6), HE ALSO REMOVED A BENIGN TUMOR CAUSED BY METAL IONS. MY RECOVERY IS AN EXTREMELY DIFFICULT AND SLOW ONE. I FEEL YOUR AGENCY NEEDS TO KNOW OF THE RISK OF BREAKAGE OF THIS PROSTHESIS WHICH UNIQUELY IS COMPRISED OF SEPARATE PARTS, INSTEAD OF A SOLID UNIT AND ADDITIONALLY THE RISK OF METAL IONS CAUSING TUMORS FROM THE METAL ON METAL INTERACTION. THE PEOPLE FROM WRIGHT MEDICAL TECHNOLOGY, INC. ADVERTISED THAT THE SPECIFIC IMPLANT THAT I WOULD RECEIVE WOULD HAVE A LOW CHANCE OF DISLOCATION, BETTER LUBRICATION, AND DECREASED WEAR. OBVIOUSLY TWO OF THESE CLAIMS ARE ERRONEOUS. THIS COMPANY, I LATER LEARNED HAD FAILURES WITH MY TYPE OF IMPLANT AND PROBLEMS WITH METALLOSIS. I WAS NEVER WARNED BY THE COMPANY. IT IS MY DESIRE TO BRING THESE FACTS TO YOUR ATTENTION AND HOPEFULLY OTHERS ARE NOT LITERALLY VICTIMS OF HIS HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547549 HIP PROSTHESIS COBALT + CHROMIUM METAL ON METAL HIP PROSTHESIS COBALT + CHROMIUM METAL ON METAL KWA WRIGHT MEDICAL TECH. INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention