BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 504805 · Received January 6, 2004

    Report

    Report Number
    504805
    Event Type
    Injury
    Date Received
    January 6, 2004
    Date of Event
    November 25, 2003
    Report Date
    December 30, 2003
    Manufacturer
    BIOMET
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY IN 1988 AND HAD PROGRESSIVE PAIN. PT UNDERWENT REVISION SURGERY IN 2003. WEAR AND DELAMINATION ON THE ARTICULAR SURFACE OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET AGC MOLDED INTERLOK TIBIAL 8X75MM HSH BIOMET * 600360

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R