BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 518153 · Received March 12, 2004

    Report

    Report Number
    518153
    Event Type
    Injury
    Date Received
    March 12, 2004
    Date of Event
    February 4, 2004
    Report Date
    February 24, 2004
    Manufacturer
    BIOMET
    Product Code
    HWC
    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

    PT HAD A LEFT HIP ARTHROPLASTY IN 1999. IS ADMITTED FOR REVISION OF LEFT HIP ARTHROPLASTY. DURING THE PROCEDURE THE HEAD, ACETABULAR LINER, AND FEMORAL COMPONENTS WERE ALL REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET TOTAL HIP COMPONENTS/LOW PROFILE SELF-TAPPING BONE SCREW HWC BIOMET * 582480
    2 BIOMET UNIVERSAL ACETABULAR SHELL KWY BIOMET, INC. * 150130
    3 BIOMET LOW PROFILE SELF TAPPING BONE SCREW KWY BIOMET, INC. * 251084
    4 BIOMET MODULAR HEAD COMPONENT KWY BIOMET, INC. * 589070
    5 BIOMET BI-METRIC PRIMARY FEMORAL COMPONENT POROUS COATED KWY BIOMET, INC. * 488748
    6 BIOMET RING LOC ACETABULAR LINER KWY BIOMET, INC. * 582370

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R