BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 1066870 · Received June 26, 2008

    Report

    Report Number
    1066870
    Event Type
    Injury
    Date Received
    June 26, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BIOMET ORTHOPEDICS, 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

    UPON ENTERING THE LEFT KNEE, MODERATELY ADVANCED METALLOSIS WITH DARKENING OF THE SYNOVIUM WAS PRESENT IN THE SUPRAPATELLAR POUCH AND LATERAL RECESSES AND EXTENSIVE SYNOVECTOMY WAS PERFORMED. TYPE: ASCENT PRIMARY LIPPED BEARING 10MM X 71/75MM. REF #: 179320. LOT #: 017560. TYPE: ALL POLY PATELLAR BUTTON. REF #: 11-150840. LOT #: 490000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ASCENT PRIMARY LIPPED BEARING 10MM X 71/75MM HSA BIOMET ORTHOPEDICS, INC. 017560
    2 BIOMET ALL POLY PATELLAR BUTTON HTG BIOMET ORTHOPAEDICS, INC. 490000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention