BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS

    MDR report key: 4021141 · Received August 19, 2014

    Report

    Report Number
    4021141
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT OF THE LEFT HIP WITH REMOVAL OF THE BIPOLAR HEAD DUE TO INFECTION. THE SURGICAL WOUND WAS NOTED WITH CHRONIC INFECTION AND PURULENCY. BLOOD CULTURES FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499200 BIOMET ORTHOPEDICS MODULAR HEAD COMPONENT 28MM KWA BIOMET ORTHOPEDICS 660210

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention