BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET

    MDR report key: 18656 · Received October 12, 1994

    Report

    Report Number
    18656
    Event Type
    Other
    Date Received
    October 12, 1994
    Date of Event
    June 23, 1993
    Report Date
    October 6, 1994
    Manufacturer
    BIOMET, INC.
    Product Code
    HTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY FOR LEFT TOTAL HIP REPLACEMENT, THE HEAD OF A FLEXIBLE REAMER 12 MM BROKE OFF INSIDE OF THE PT'S FEMUR. UNABLE TO SURGICALLY REMOVE REAMER HEAD. INCISION CLOSED WITH REAMER HEAD LEFT INSIDE PT. REMAINDER OF REAMER HAS BEEN IMPOUNDED IN THE HOSPITAL PATHOLOGY DEPT. POTENTIAL FOR INFECTION RELATED TO DEVICE BEING RETAINED INSIDE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET FLEXIBLE REAMER HTO BIOMET, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other