BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOBOND COPOLYMER BONE CEMENT

    MDR report key: 57404 · Received December 17, 1996

    Report

    Report Number
    57404
    Event Type
    Injury
    Date Received
    December 17, 1996
    Date of Event
    June 26, 1996
    Report Date
    July 1, 1996
    Manufacturer
    ZIMMER SOUTHWEST OHIO
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH OSTEOARTHRITIS IN LEFT HIP UNDERWENT LEFT TOTAL HIP REPLACEMENT. SURGEON NOTED THAT THE CEMENT SOLIDIFIED BEFORE THE PROSTHESIS COULD NBE SEATED FULLY. THIS THEN REQUIRED REMOVAL OF THE PROSTHESIS AND CEMENT AND REVISION OF LONG STEM CEMENTED COMPONENT. ON 6/26/96 AT 1500, X-RAY CONFIRMED THAT ACETABULAR AND INTRAMEDULLARY COMPONENTS APPEAR WELL POSITIONED. PT IS WALKING IN PHYSICAL THERAPY WITH WALKER. ANTICIPATED DISCHARGE TO HOME. ON SAME DAY, SAME LOT NUMBER OF BONE CEMENT WAS USED ON A DIFFERENT PT AND NO COMPLICATIONS WERE NOTED. PRODUCT WAS MIXED AT TEMP APPROX BETWEEN 65-70 DEGREES, USING THE VACUUM MIXING SYSTEM. TWO PACKETS OF POWDER WAS PLACED IN SYSTEM, THEN 2 BOTTLES LIQUID. MIXING TIME APPROX 4 MINS AND 15 SECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOBOND COPOLYMER BONE CEMENT Implant DOUGH TYPE 40GM POLYMER POWDER/20ML MONOMER LIQUID LOD ZIMMER SOUTHWEST OHIO NA 73243600

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ZIMMER OSTEOBOND VACUUM MIXING SYSTEM