BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD FEMORAL KNEE

    MDR report key: 1991110 · Received February 11, 2011

    Report

    Report Number
    3002806535-2011-00019
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 14, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    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. SURGEON REPORTED NO OBVIOUS INFECTION AND NO SIGNS OF LOOSENING. 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

    IT WAS REPORTED THAT PT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6), 2008. PT UNDERWENT REVISION SURGERY ON (B)(6), 2010 DUE TO UNEXPLAINED PAIN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD FEMORAL KNEE NRA BIOMET UK LTD. NA 1615464

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R