BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM PS TIBIAL BEARING 12MM X 71/75MM

    MDR report key: 2625875 · Received June 22, 2012

    Report

    Report Number
    0001825034-2012-00887
    Event Type
    Injury
    Date Received
    June 22, 2012
    Date of Event
    April 14, 2012
    Report Date
    May 28, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RETURNED DEVICES AND RADIOGRAPHS COULD NOT DETERMINE WHETHER THE LOCKING BAR WAS CORRECTLY IMPLANTED DURING THE INITIAL PROCEDURE. ROOT CAUSE OF THE DISASSOCIATION COULD NOT BE DETERMINED. THIS FOLLOW-UP REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00887-1 / 00888-1).

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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: UNDER WARNINGS NUMBER 3 STATES, "THE LOCKING BAR USED TO SECURE THE TIBIAL PLATE AND TIBIAL-BEARING COMPONENTS TOGETHER MUST LOCK SECURELY INTO PLACE WITH AN AUDIBLE CLICK AT THE TIME OF IMPLANTATION. DISASSOCIATION OF THE LOCKING BAR FROM THE MODULAR TIBIAL PLATE COMPONENT HAS BEEN REPORTED. INADEQUATE SEATING OF THE LOCKING BAR CAN CAUSE DISASSOCIATION OF THE LOCKING BAR FROM THE TIBIAL PLATE COMPONENT, REQUIRING REVISION SURGERY." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00887 / 00888).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012, DUE TO THE LOCKING BAR DISASSOCIATING COMPLETELY FROM THE TIBIAL TRAY. SURGEON REMOVED PROLAPSED LOCKING BAR AND REPLACED IT WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM PS TIBIAL BEARING 12MM X 71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 793360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R