BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT

    MDR report key: 865915 · Received June 13, 2007

    Report

    Report Number
    1822565-2007-00183
    Event Type
    Injury
    Date Received
    June 13, 2007
    Date of Event
    May 2, 2007
    Report Date
    May 14, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FEMORAL COMPONENT HAS A LOT OF BONE CEMENT DEPOSITION SUGGESTING INADEQUATE BONE SUPPORT FOR FEMORAL COMPONENT AND POSSIBILITY OF MAJOR LOAD TRANSFER THROUGH JUNCTION OF FEMORAL AND STEM EXTENSION CAUSING FRACTURE. EVALUATION CODES: STEM PORTION OF FEMORAL COMPONENT IS FRACTURED THROUGH SET SCREW HOLES. REMAINING PORTION OF STEM IS STILL ATTACHED TO STEM EXTENSION. DEVICE HISTORY RECORDS INDICATE MANUFACTURE TO SPECIFICATION. SCANNING ELECTRON MICROSCOPE EXAMINATION WAS CONDUCTED ON STEM FRACTURE ON SIDE ATTACHED TO TIVANIUM EXTENSION. DUE TO LONG LENGTH OF IMPLANT STAGE MOVEMENT WAS RESTRICTED AND FRACTURE SURFACE COULDN'T BE EXAMINED THOROUGHLY. LIMITED OBSERVATION INDICATES FRACTURE OCCURRED BY FATIGUE. NO MICROMECHANISMS COULD BE DETECTED ON FEMORAL SIDE FRACTURE SURFACE DUE TO DEFORMATION AND RUB MARKS. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF FRACTURED STEM PART SHOWED CO, CR, AND MO PEAKS IN THE SPECTRUM TYPICAL OF ZIMALOY.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2005. APPROX 1.5 YEARS POST-OP, THE PT HEARD A "CLICKING NOISE" WHEN HE GOT UP OUT OF HIS CHAIR. IN 2007, THE DEVICE WAS REVISED DUE TO A FRACTURE AT THE STEM PORTION OF THE FEMORAL AT THE SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT KNEE PROSTHESIS HRZ ZIMMER, INC. NA 60273014

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R