BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HIP

    MDR report key: 1971682 · Received January 20, 2011

    Report

    Report Number
    MW5019118
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    September 15, 2010
    Report Date
    January 20, 2011
    Manufacturer
    ENCORE ORTHOPEDICS
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BECAUSE OF PAIN IN RIGHT HIP, HAD X-RAYS THAT SHOWED MY R TOTAL HIP REPLACEMENT WAS FAILING. IN (B)(6) OF 2004, I HAD AN UN-CEMENTED ENCORE LINEAR SYSTEM TOTAL HIP REPLACEMENT FOR ADVANCED ARTHRITIS OF THE RIGHT HIP. I HAD BEEN HAVING PAIN IN THE HIP AND RIGHT UPPER LEG FOR A WHILE. THE ORTHOPEDIC SURGEON FOUND WITH X-RAYS THAT A SIGNIFICANT AMOUNT OF BONE SURROUNDING THE STEM AND CUP OF THE IMPLANT HAD DISAPPEARED. PART OF THE FEMORAL CORTEX OF BONE HAD CRACKED. HE RECOMMENDED A TOTAL HIP REVISION WITH BONT GRAFTING. I AM SCHEDULED FOR SURGERY (B)(6) OF 2011. I HAVE NOT BEEN ABLE TO FIND ANY RECALL OF THIS ENCORE SYSTEM. I WOULD LIKE YOUR ADVICE ON WHAT I SHOULD DO WITH THE IMPLANT WHEN IT IS REMOVED, DO I SEND IT TO THE COMPANY OR DOES THE HOSPITAL. DOES MY DOCTOR REPORT THE PROBLEM ALSO TO THE COMPANY AND THE FDA?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL HIP HIP STEM SIZE 15 LZO ENCORE ORTHOPEDICS 229932
    2 FEMORAL HIP HEMISPHERICAL SHELL, W/HOLES 56MM DIA. LPH ENCORE ORTHOPEDICS 203882
    3 FEMORAL HIP ENCORE FEMORAL HEAD 28MM DIA. + 7.0MM NECK LZO ENCORE ORTHOPEDICS 968531
    4 FEMORAL HIP SCREW LZO ENCORE ORTHOPEDICS 941721
    5 FEMORAL HIP LINER METAL/METAL KWA ENCORE ORTHOPEDICS 958171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S