BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRA - DRIVE DISK DRILL

    MDR report key: 806718 · Received January 12, 2007

    Report

    Report Number
    1825034-2007-00011
    Event Type
    Other
    Date Received
    January 12, 2007
    Date of Event
    November 22, 2006
    Report Date
    December 18, 2006
    Manufacturer
    BIOMET, INC.
    Product Code
    LZV
    PMA / PMN Number
    K031280
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COMPLEX LEFT REVISION TOTAL HIP ARTHROPLASTY, THE TIP SECTION OF THE DISK DRILL FRACTURED. ATTEMPTS TO REMOVE THE FRAGMENT WERE UNSUCCESSFUL; TIP SECTION REMAINS IMPLANTED IN THE PATIENT'S FEMORAL CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA - DRIVE DISK DRILL JDX LZV BIOMET, INC. NA 423872

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other