BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 519103 · Received January 7, 2004

    Report

    Report Number
    MW1031627
    Event Type
    Injury
    Date Received
    January 7, 2004
    Report Date
    January 7, 2004
    Manufacturer
    BIOMET ORTHO INC.
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD REVISION OF THEIR LEFT TOTAL KNEE IN 2002 FOR THE SAME PROBLEM, LOCKED LEFT TOTAL ARTHROPLASTY. THEY ARE NOW ALMOST 8 WEEKS POSTOP. ALL OF A SUDDEN LAST NIGHT IT LOCKED FOR THEM IN POSITION ONCE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET MAXIM CONSTRAINED TIBIAL BEARING HSH BIOMET ORTHO INC. * *
    2 BIOMET MAXIM CONSTRAINED TIBIAL BEARING HSH BIOMET ORTHO INC. * *
    3 BIOMET MAXIM CONSTRAINED TIBIAL BEARING HSH BIOMET ORTHO INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention