BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 1033392 · Received April 22, 2008

    Report

    Report Number
    MW5006370
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BIOMET SURGICAL SPECIALTIES
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A TOTAL LEFT HIP REPLACEMENT IN 2007, AND WAS DISCHARGED TO HOME FOUR DAYS LATER. A FALL AT HOME THREE DAYS LATER, RESULTED IN A FRACTURE OF THE LEFT HIP AND A RETURN TO THE OPERATING ROOM FOR A REVISION OF THE LEFT TOTAL HIP. UNEVENTFUL RECOVERY. THREE MONTHS LATER, HE DEVELOPED SWEATS AND CHILLS, HIP AREA WAS ASPIRATED AND INFECTION CONFIRMED. IN THE SAME MONTH, SURGICAL REMOVAL OF THE LEFT HIP IMPLANTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET BIOMET MALLORY HEAD KWY BIOMET SURGICAL SPECIALTIES 514780
    2 BIOMET BIOMET TAPERLOC LAT FMRL 11-103207 KWY BIOMET SURGICAL SPECIALTIES 436520
    3 BIOMET BIOMET SCREW TI LOW PROFILE HWC BIOMET SURGICAL SPECIALTIES 718310
    4 BIOMET BIOMET HEAD MOD COCR KWY BIOMET SURGICAL SPECIALTIES 670710
    5 BIOMET ACETAB LINER KWB BIOMET SURGICAL SPECIALTIES 170530

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability