BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 1202360 · Received October 10, 2008

    Report

    Report Number
    MW5008663
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    August 25, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2007 - LEFT TOTAL HIP ARTHROPLASTY. ON ELEVEN DAYS LATER - ED VISIT - SEROMA. ON APPROX ONE AND A HALF MONTHS LATER - LEFT HIP INCISION AND DRAINAGE OF SEROMA - CULTURES DONE AND NEGATIVE . IN 2008 - ED VISIT - LEFT HIP PAIN. ON FIVE MONTHS LATER - REVISION LEFT TOTAL HIP ARTHROPLASTY - ACETABULUM AND FEMORAL HEAD ONLY - DUE TO ACETABULAR LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET C2A TAPER ACETABULAR SYSTEM LINER MRA BIOMET ORTHOPEDICS 164910
    2 BIOMET C2A TAPER ACETABULAR SYSTEM HEAD MRA BIOMET ORTHOPEDICS 244650

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R