BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR PLASMA Z STEM FLARE STD COLLOR NO TAPER

    MDR report key: 1090803 · Received July 30, 2008

    Report

    Report Number
    MW5007863
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    A WRIGHT MEDICAL GROUP COMPANY
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE WALKING PT FELT A POP IN HIS RIGHT HIP AND WAS UNABLE TO WALK. PRESENTED TO THE EMERGENCY DEPT AND X-RAY REVEALED FRACTURED HIP PROSTHESIS WITH RESULTANT VARUS FORMATION OF THE RIGHT HIP. NO BONE FRACTURE OR DISLOCATION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR PLASMA Z STEM FLARE STD COLLOR NO TAPER NONE KWY A WRIGHT MEDICAL GROUP COMPANY 065223267
    10 CONSERVE TOTAL A-CLASS HEAD W/BFH TECH. MEDIUM NECK NONE KWA WRIGHT MEDICAL TECHNOLOGY. INC. 106380251
    2 PROFEMUR PLASMA Z STEM NONE KWY A WRIGHT MEDICAL GROUP COMPANY 026312024
    3 CONSERVE PLUS SPIKED CUP NONE KWB A WRIGHT MEDICAL GROUP COMPANY 01468027
    4 PROFEMUR NECK NEUTRAL LONG NONE KWY A WRIGHT MEDICAL GROUP COMPANY 056343913
    5 EXTEND HIP STEM NONE KWY A WRIGHT MEDICAL GROUP COMPANY 11234142
    6 CABLE SYSTEM CRIMP SLEEVE NONE JDQ BIOMET ORTHOPEDICS, INC. 828220
    7 BOBALT CHROME CABLE NONE JDQ BIOMED ORTHOPEDICS, INC. 183610
    8 CABLE SYSTEM CRIMP SLEEVE NONE JDQ BIOMET ORTHOPEDICS, INC. 213830
    9 COBALT CHROME CABLE NONE JDQ BIOMET ORTHOPEDICS, INC. 183610

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization CONSERVE PLUS SPIKED CUP SHELL SIZE 62MM| CONSERVE TOTAL A CLASS HEADW/BFH| PROFEMUR NECK NEUTRAL LONG SIZE NEUTRAL LONG