BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD TIBIAL BEARING

    MDR report key: 2003554 · Received February 21, 2011

    Report

    Report Number
    3002806535-2011-00023
    Event Type
    Injury
    Date Received
    February 21, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    K080528
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT KNEE PROCEDURE ON (B)(6), 2006. PT UNDERWENT REVISION SURGERY ON (B)(6), 2011 DUE TO LOOSENING OF TIBIAL COMPONENT (ASEPTIC), MEDIAL PLATEAU COLLAPSE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD TIBIAL BEARING JWH BIOMET UK LTD. NA 1143128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R