BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 71MM TIBIAL PLATE

    MDR report key: 1052132 · Received May 22, 2008

    Report

    Report Number
    MW5007013
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    March 31, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BIOMET
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY IN 2005 AT ANOTHER HOSPITAL. IN 2008 SHE UNDERWENT A REVISION OF THE ORIGINAL PROCEDURE DUE TO THE LOCKING BAR BACKING OUT OF THE ORIGINAL COMPONENT. THE LOCKING PIN HAD ACTUALLY ESCAPED THE JOINT AND WAS FOUND IN THE SUBCUTANEOUS TISSUE MEDIALLY. THE PIN WAS REMOVED AS WELL AS THE INDWELLING POLY. THE WOUND WAS COPIOUSLY IRRIGATED AND A 12 PS PLUS POLY LINER WAS PUT IN PLACE. A NEW LOCKING PIN WAS ENTERED FROM LATERAL TO MEDIAL BY TAPPING IT INTO POSITION. DATES OF USE: 2005 - 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET 71MM TIBIAL PLATE NONE HSH BIOMET 141223 841990

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability