BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIO-MET

    MDR report key: 438571 · Received January 6, 2003

    Report

    Report Number
    438571
    Event Type
    Death
    Date Received
    January 6, 2003
    Report Date
    December 16, 2002
    Manufacturer
    BIOMET
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT REPLACEMENT OF FAILED CEMENTED HIP REPLACEMENT OF RIGHT HIP. DISCHARGED FROM REHAB. PT READMITTED TWO MONTHS LATER FOR INFECTION OF R HIP. PT DISCHARGED 8 DAYS LATER. PT READMITTED 18 DAYS LATER FOR REMOVAL OF HIP REPLACEMENT. PT HAD PANCREATITIS ON ADMIT. PT HAD ACUTE & CHRONIC RENAL FAILURE & WENT ON TO DEVELOP ADULT RESPIRATORY DISTRESS SYNDROME. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-MET SEE ATTAHCED-HIP REPLACEMENT DEVICE JDI BIOMET SEE ATTACHED *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H