BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS INC

    MDR report key: 998455 · Received January 18, 2008

    Report

    Report Number
    MW4004332
    Event Type
    Injury
    Date Received
    January 18, 2008
    Date of Event
    December 15, 2007
    Report Date
    January 14, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD BI-POLAR HIP PROSTHESIS IMPLANTED IN 2007. HE WAS RETURNED TO SURGERY ON ABOUT 15 DAYS LATER FOR EXPLANTATION OF HIP PROSTHESIS. THE BALL HAD SEPARATED FROM THE STEM, CAUSE UNKNOWN, NEW PROSTHESIS IMPLANTED. MFR REP TOOK OLD PROSTHESIS AND RETURNED TO BIOMET FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS INC BI-POLAR HIP COMPONENT JDI BIOMET, INC. 163661 199990
    2 BIOMET ORTHOPEDICS INC BI-POLAR HIP COMPONENT JDI BIOMED 1-765222 933690
    3 BIOMET ORTHOPEDICS INC BI-POLAR HIP COMPONENT JDI BIOMET 139202 794950

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization