BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H INTERLOK (NTS)

    MDR report key: 360655 · Received November 9, 2001

    Report

    Report Number
    1825034-2001-00106
    Event Type
    Injury
    Date Received
    November 9, 2001
    Date of Event
    September 24, 2001
    Report Date
    November 9, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    JDT
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED IN 1992. PROXIMAL PORTION OF FEMORAL STEM COMPONENT LOOSENED AND SUBSEQUENTLY FRACTURED. REVISION PERFORMED IN 2001, NOTING INTRAOPERATIVELY, THAT THE DISTAL PORTION OF THE FEMORAL STEM REMAINED WELL FIXED. BOTH DISTAL AND PROXIMAL PIECES OF STEM COMPONENT WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50503 M/H INTERLOK (NTS) PROSTHESIS, HIP, COMP. JDT BIOMET, INC. NA 776150

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R