BEUDAMED
    FDA Adverse Event Other Summary report: N

    BISECTED FEMUR SHAFT

    MDR report key: 509182 · Received January 26, 2004

    Report

    Report Number
    MW1030924
    Event Type
    Other
    Date Received
    January 26, 2004
    Date of Event
    December 15, 2003
    Report Date
    January 26, 2004
    Manufacturer
    LIFENET
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNDERWENT ORIF RIGHT FEMUR WITH BONE GRAFTING. A HEMATOMA WAS REMOVED FROM THE FRACTURE SITE AND ONCE THE FRACTURE WAS STABLE, A CORTICAL ONLAY ALLOGRAFT WAS PLACED LATERALLY. PT DID WELL UNTIL 2 MONTHS LATER WHEN THEY WERE READMITTED WITH PAIN AND AN OCCULT FRACTURE. PT UNDERWENT A RIGHT REVISION OF TOTAL HIP ARTHROPLASTY. ON EVENT DATE PT WAS RE-ADMITTED WITH A SEPTIC RIGHT HIP AND UNDERWENT IRRIGATION AND DEBRIDEMENT. PURULENT MATERIAL WAS FOUND UNDERNEATH THE BONE GRAFT AS WELL AS IN THE JOINT. CULTURES OF THE JOINT AND FLUID GREW CITROBACTER KOSERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BISECTED FEMUR SHAFT ALLOGRAFT LMO LIFENET * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other