BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET INC.

    MDR report key: 267825 · Received March 3, 2000

    Report

    Report Number
    267825
    Event Type
    Injury
    Date Received
    March 3, 2000
    Date of Event
    February 1, 2000
    Report Date
    February 2, 2000
    Manufacturer
    BIOMET INC.
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PREOPERATIVE XRAYS OF RT KNEE REVEALED A PORTION OF THE LOCKING CLIP LOCATED ON THE TIBIAL IMPLANT FRACTURED. DURING LT TOTAL KNEE ARTHROPLASTY IN 2000, SURGEON REPLACED LOCKING CLIP IN RIGHT KNEE. RIGHT TOTAL KNEE ARTHROPLASTY ORIGINALLY PERFORMED IN 1996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET INC. LOCKING BAR ONLY MAXIM COBALT CHROME I-BEAM TRAY 83 HSH BIOMET INC. 141226 509040

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention