BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD LOCK-ON FEMORAL IMPACTOR

    MDR report key: 1934426 · Received November 23, 2010

    Report

    Report Number
    3002806535-2010-00094
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HWA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EVALUATION IN PROCESS, BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A F/U REPORT WILL BE SENT TO THE FDA. THIS REPORT FILED ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT KNEE PROCEDURE ON (B)(6) 2010. WHILE INSERTING THE IMPLANT, THE METAL TAB ON THE FEMORAL IMPACTOR BROKE. NO PT INJURY OR DELAY IN SURGERY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD LOCK-ON FEMORAL IMPACTOR HWA BIOMET UK LTD. NA BT086482

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization