BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-DRIVE DISK DRILL

    MDR report key: 526187 · Received May 20, 2004

    Report

    Report Number
    1825034-2004-00051
    Event Type
    Injury
    Date Received
    May 20, 2004
    Date of Event
    May 13, 2004
    Report Date
    May 14, 2004
    Manufacturer
    ARTHROTEK/BIOMET
    Product Code
    LZV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING REVISION TOTAL HIP ARTHROPLASTY PERFORMED IN 2004, IT WAS REPORTED THAT TOOL FRACTURED DURING USE OF ULTRA DRIVE CEMENT REMOVAL SYSTEM. SURGERY WAS EXTENDED TO REMOVE DISK DRILL TIP FROM DISTAL PORTION OF THE FEMUR. FURTHERMORE, DURING REATTACHMENT OF THE TROCHANTER, IT WAS REPORTED THAT TROCHANTER BOLT FRACTURED. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-DRIVE DISK DRILL CEMENT REMOVAL SYSTEM LZV ARTHROTEK/BIOMET NA 732290

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R