BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 518148 · Received March 12, 2004

    Report

    Report Number
    518148
    Event Type
    Injury
    Date Received
    March 12, 2004
    Date of Event
    January 22, 2004
    Report Date
    February 26, 2004
    Manufacturer
    BIOMET
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PT HAS HAD LEFT HIP PAIN FOR 3 TO 4 YEARS. TOTAL LEFT HIP ARTHROPLASTY IN 1973, REVISION IN 1998. HAS PAIN WITH ALL AMBULATION. X-RAYS SHOW THE STEM HAS LOOSENED. DURING THE PROCEDURE THE SURGEON DISCOVERED THE STEM WAS QUITE LOOSE. THE STEM WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET TOTAL HIP COMPONENTS/RING LOC ACETABULAR LINER KWB BIOMET * 224750
    2 BIOMET UNIVERSAL ACETABULAR SHELL JDI BIOMET * 850750
    3 BIOMET BI-METRIC FEMORAL COMPONENT JDI BIOMET * 733470
    4 BIOMET MODULAR HEAD COMPONENT JDI BIOMET, INC. * 434320

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R