BEUDAMED
    FDA Adverse Event Death Summary report: N

    TI LOW PROFILE SCREW

    MDR report key: 432940 · Received December 13, 2002

    Report

    Report Number
    1825034-2002-00167
    Event Type
    Death
    Date Received
    December 13, 2002
    Date of Event
    May 8, 2001
    Report Date
    December 10, 2002
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED VIA LEGAL COMPLAINT ALLEGING WRONGFUL DEATH ACTION. PT REPORTEDLY UNDERWENT REVISION RIGHT TOTAL HIP ARTHROPLASTY IN 2001. SUBSEQUENTLY PT WAS ALLEGEDLY DIAGNOSED WITH (MRSA) METHICILLIN RESISTANT STAPH AUREUS AND COMPONENTS WERE REMOVED 14 WEEKS LATER. THE CO HAS NO INFO THAT THIS INCIDENT OF INFECTION IS ANY WAY RELATED TO BIOMET DEVICES IMPLANTED. THE CO IS CONTINUING TO GATHER FURTHER INFO, BUT TO DATE, THERE IS NO INFO THAT WOULD LEAD BIOMET TO CONCLUDE THAT THE DEVICES USED CAUSED THE REPORTED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LOW PROFILE SCREW PROSTHESIS, HIP, COMP. JWH BIOMET, INC. NA 066910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| H| R