BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 1593105 · Received January 28, 2010

    Report

    Report Number
    MW5014590
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    December 22, 2009
    Report Date
    January 28, 2010
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFECTED LEFT TOTAL HIP ARTHROPLASTY. ORIGINAL TOTAL LEFT HIP REPLACEMENT SURGERY ON (B) (6)2009. DÉBRIDEMENT AND POLYETHYLENE EXCHANGE ON (B) (6) 2009. INNER SURFACE OF POLYETHYLENE APPEARED SCRATCHED, RETURNED TO MFG FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET BIOMET LEFT TOTAL HIP COMPONENTS JDI BIOMET, INC. EPOLY 40MM + 3 964250

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR