BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 513417 · Received February 24, 2004

    Report

    Report Number
    MW4003691
    Event Type
    Injury
    Date Received
    February 24, 2004
    Date of Event
    February 12, 2003
    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
    OTHER HEALTH CARE PROFESSIONAL

    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. PT IS NOW ALMOST 8 WEEKS POSTOP. ALL OF A SUDDEN LAST NIGHT IT LOCKED IN POSITION ONCE AGAIN. IN 2003 CLOSED REDUCTION OF POSTERIOR DISLOCATION OF TIBIA ON THE FEMUR AND APPLICATION OF KNEE IMMOBILIZER. 2003 TO SURGERY FOR REVISION OF LEFT TOTAL KNEE ARTHROPLASTY DISLOCATION OF POSTERIOR STABILIZED TIBIA FROM THE FEMUR. SURGERY-REVISION OF LEFT TOTAL KNEE ARTHROPLASTY WITH REDUCTION & EXCHANGE OF POLYETHYLENE SPACER.

    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 POLY BEARING HSH BIOMET ORTHO INC. * *
    3 BIOMET MAXIM CONSTRAINED TIBIAL BEARING HSH BIOMET ORTHO INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention