BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS

    MDR report key: 600032 · Received May 4, 2005

    Report

    Report Number
    600032
    Event Type
    Injury
    Date Received
    May 4, 2005
    Date of Event
    April 7, 2005
    Report Date
    April 21, 2005
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT BI-POLAR HIP ARTHROPLASTY IN 2005. FOLLOWING THIS PROCEDURE, BI-POLAR COMPONENT DISASSOCIATED FROM THE CALCAR FEMORAL PROSTHESIS. PT RETURNED TO SURGERY 2005 TO REPLACE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS RINGLOC BI-POLAR CUP 28MM X 47 MM KWY BIOMET ORTHOPEDICS 11-165218 780660

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention