BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM TAPER ADAPTOR

    MDR report key: 2041935 · Received March 30, 2011

    Report

    Report Number
    3002806535-2011-00041
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    December 9, 2010
    Report Date
    March 2, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    NA
    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. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    PT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6), 2008. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO LATE INFECTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNUM TAPER ADAPTOR KWA BIOMET UK LTD. NA 1345019

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R