BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER NITRIDED

    MDR report key: 1031557 · Received April 18, 2008

    Report

    Report Number
    1822565-2008-00191
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE TAPER STEM HAS FRACTURED AT THE JUNCTION WITH THE CONE BODY. SCANNING ELECTRON MICROSCOPY ANALYSIS SHOWS THAT THE FRACTURE HAS OCCURRED BY FATIGUE. THE PACKAGE INSERT CONTAINS STATEMENTS WARNING THAT DEVICE FRACTURES MAY OCCUR WHERE EXCESSIVE PT WEIGHT, EXCESSIVE PT ACTIVITY, OR LACK OR PROXIMAL SUPPORT OF THE BODY ARE INVOLVED. NO ALL OF THESE FACTORS ARE KNOWN FOR THIS CASE. THERE IS NO DEFINITIVE INDICATION THAT DESIGN OR MANUFACTURE OF THE DEVICE CONTRIBUTED TO THE OUTCOME DESCRIBED HERE. RISK MANAGEMENT ACTIVITY HAS BEEN INITIATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THIS REPORT WILL BE AMENDED. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY ANALYSIS SHOWED BEACH MARKS AND FATIGUE STRIATIONS INDICATING THAT FRACTURE OCCURRED BY FATIGUE. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF THE STEM MATERIAL SHOWED TI, AL AND V ELEMENTAL PEAKS TYPICAL OF TIVANIUM ALLOY.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICES WERE IMPLANTED IN 2004. REVISION SURGERY OCCURRED IN 2008, DUE TO BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER NITRIDED HIP PROSTHESIS KWY ZIMMER, INC. NA 77491100

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R