BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 1066874 · Received June 26, 2008

    Report

    Report Number
    1066874
    Event Type
    Injury
    Date Received
    June 26, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BIOMET ORTHOPAEDICS, INC.
    Product Code
    HSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERE BLACK SYNOVIAL DEPOSITS WERE VISUALIZED THROUGHOUT THE PT'S RIGHT KNEE; VERY THICKENED, WHICH APPEARED TO BE A METALLOSIS TYPE DEPOSIT. TWO BIOMET DEVICES INVOLVED IN THIS REPORT: TYPE: ASCENT PRIMARY CURVED BEARING 12 X 79/83. PART #: 179381. LOT #: 949630. TYPE: ALLPOLY PATELLAR BUTTON. PART #: 11-150842. LOT #: 552400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ASCENT PRIMARY CURVED BEARING 12 X 79/83 HSA BIOMET ORTHOPAEDICS, INC. 949630
    2 BIOMET ALLPOLY PATELLAR BUTTON HTG BIOMET ORTHOPEDICS INC. 552400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention