BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN BOX FEMORAL 62.5MM LEFT INTERLOK

    MDR report key: 1875188 · Received October 19, 2010

    Report

    Report Number
    1825034-2010-00437
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: DISLOCATION AND SUBLUXATION SUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO MEDIAL LIGAMENT INSTABILITY. THE FEMORAL COMPONENT AND TIBIAL BEARING WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD PS OPEN BOX FEMORAL 62.5MM LEFT INTERLOK PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 728840

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R