BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR FEMORAL COMPONENT

    MDR report key: 1910735 · Received November 23, 2010

    Report

    Report Number
    3002806535-2010-00095
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    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 US. 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. THIS REPORT WAS FILED ON (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT HIP PROCEDURE ON (B)(6) 2007. PT UNDERWENT REVISION SURGERY ON (B)(6) 2010 DUE TO PT INFECTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD CR FEMORAL COMPONENT JWH BIOMET UK LTD. NA 1328477

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R