BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET 9.5 MM DISK DRILL TIP

    MDR report key: 790825 · Received December 5, 2006

    Report

    Report Number
    MW1041261
    Event Type
    Other
    Date Received
    December 5, 2006
    Date of Event
    November 22, 2006
    Report Date
    December 5, 2006
    Manufacturer
    BIOMET. INC.
    Product Code
    LZV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT COMPLEX LEFT TOTAL HIP ARTHROPLASTY REVISION OF FEMORAL COMPNENT AND MODULAR EXCHANGE OF ACETABULAR COMPONENT POLYETHYLENE LINER. LEFT HIP JOINT TOTAL SYNOVECTOMY FOR POLYTHYLENE WEAR DEBRIS SYNDROME AND EXCHANGE OF ACETABULAR COMPONENT, MODULAR LOCKING MECHANISM. MORELAND OSTEOTOMES AND A ULTRADRIVE CEMENT REMOVER WITH A 9.5 MM DISC DRILL TIP WERE USED TO REMOVE CEMENT. DURING THIS PORTION OF THE PROCEDURE THE TIP BROKE OFF ITS SHAFT IN THE FEMORAL CANAL. AN INTRAOPERATIVE X-RAY SHOWED THAT THE TIP HAD MIGRATED DOWN TO THE JUNCTION OF THE MIDDLE AND DISTAL THIRD OF THE FEMUR. AN ATTEMPT TO GRASP IT WITH A RONGUER WAS UNSUCCESSFUL AND THE TIP WAS LEFT IN THE INTRAMEDULLARY DISTAL ASPECT OF THE FEMORAL CANAL. USED IN CONJUNCTION WITH ULTRADRIVE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET 9.5 MM DISK DRILL TIP * LZV BIOMET. INC. 423872 376980

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other