BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY ORTHOPEDICS

    MDR report key: 577599 · Received February 28, 2005

    Report

    Report Number
    MW1034771
    Event Type
    Malfunction
    Date Received
    February 28, 2005
    Date of Event
    February 16, 2005
    Report Date
    February 17, 2005
    Manufacturer
    DEPUY/JOHNSON AND JOHNSON
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    2. THE TERRITORY SALES OFFICE DESCRIBED THE INSTRUMENT SET AS A ROANOKE AREA "FLOATER" (LOANER) SET, INDICATING THAT IT IS USED BY SEVERAL HOSPITALS IN THE AREA. (THE REPORTING USER FACILITY) DOES NOT HAVE A DEDIDICATED SET OF INSTRUMENT. LOANER INSTRUMENT SETS ARE TYPICALLY USED AT ONE HOSP, CLEANED AND AUTOCLAVED BY THAT HOSPITAL'S CENTRAL STERILE SERVICES, AND ARE THEN RETURNED TO THE SALES OFFICE. THE SALES OFFICE DOES NOT HAVE THE CAPABILITY TO CLEAN AND AUTOCLAVE INSTRUMENT SETS ON SITE. TEXT IN THE REPORT NUMBER MW1034771 EVENT DESCRIPTION SECTION (B5) INDICATES THAT THE REPORT WAS GENERATED BY THE USER FACILITY ON 2/17/2005, BUT THE EVENT DATE IS NOT GIVEN. THE TERRITORY SALES OFFICE WAS UNABLE TO DETERMINE THE HOSP THAT HAD HAD THE INSTRUMENT SET JUST PRIOR TO THE USER FACILITY'S RECEIPT.

    Description of Event or Problem · 1

    INSTRUMENT TRAYS WERE DELIVERED TO STERILE PROCESSING ON LOAN FROM THE COMPANY. DURING INITIAL INSPECTION, DRIED BLOOD WAS FOUND ON INSTRUMENTS. THE INSTRUMENTS HAD TRAVELED TO THIS LOCATION BY COURIER WITH GROSS CONTAMINATION PRESENT. THE INSTRUMENTS WERE PROPERLY CLEANED AND STERILZED PRIOR TO BEING USED ON THE PT, BUT THE INSTRUMENTS DID NOT MEET STANDARDS WHEN DELIVERED. THESE ARE THE ITEMS THAT WERE DIRTY: FLUTE FEMORAL AND TIBIAL STEM TRIALS 10 X 125 FEM, 20 X 125 FEM; MODULAR PLUS TIBIAL INSTRUMENTS AND WEDGE TRIALS - JJO 96-6315.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ORTHOPEDICS J AND J KNEE REPLACEMENT SYSTEM JWH DEPUY/JOHNSON AND JOHNSON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other