BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2071525 · Received April 15, 2011

    Report

    Report Number
    2071525
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 7, 2011
    Report Date
    April 15, 2011
    Manufacturer
    DEPUY
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD TO HAVE REVISION SURGERY FOR A FAILED TOTAL HIP DEVICE. THE INITIAL IMPLANTATION OF THE DEVICE TOOK PLACE FOUR YEARS AND TWO MONTHS BEFORE EXPLANT. THE DEVICE WAS A DEPUY CERAMIC ON CERAMIC TOTAL HIP ARTHROPLASTY, AND ANALYSIS IS IN PROGRESS. THE FEMORAL HEAD AND ACETABULAR LINER COMPONENTS FRACTURED IN-VIVO, BUT THERE WAS NO PERMANENT HARM TO THE PATIENT AS SHE WAS ABLE TO BE REVISED TO ANOTHER TOTAL HIP ARTHROPLASTY (IT WAS JUST SOONER THAN WOULD BE IDEAL). CLINICALLY, THE PATIENT EXPERIENCED PAIN AND MECHANICAL SYMPTOMS (CLICKING/SNAPPING, CATCHING, ETC) PRIOR TO HER REVISION SURGERY. ALL COMPONENTS ARE DEPUY. THE FEMORAL STEM IS AN S-ROM MODULAR SYSTEM, AND THE TRUNION OF THE DEVICE WAS MADE LARGER WITH A SHEATH/JACKET TO ACCOMMODATE THE FEMORAL HEAD. THE ACETABULAR SHELL IS A DURALOC MODEL, AND BOTH THE FEMORAL HEAD AND ACETABULAR LINER ARE ALUMINA CERAMIC COMPONENTS. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PROSTHESIS, HIP, CERAMIC ON CERAMIC JDI DEPUY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR