BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 96028 · Received June 2, 1997

    Report

    Report Number
    96028
    Event Type
    Other
    Date Received
    June 2, 1997
    Date of Event
    May 5, 1997
    Report Date
    May 12, 1997
    Manufacturer
    BIOMET, INC.
    Product Code
    LZV
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, LEFT TOTAL HIP REVISION, TIP OF ULTRASONIC DEVICE BROKE, WHILE REMOVING CEMENT. TIP OF DEVICE LEFT IN LEFT FEMORAL CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ULTRA DEVICE TOOL 6MM PLUG PULLER LZV BIOMET, INC. * 1625809704

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other