BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD TIBIAL TRAY

    MDR report key: 2153389 · Received June 29, 2011

    Report

    Report Number
    3002806535-2011-00100
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 2, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NOTE FROM HOSPITAL INDICATED, "ALL COMPONENTS OBSERVED TO BE WELL FIXED WITH NO OBVIOUS REASON FOR PAIN NOTED". CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT FILED ON (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6), 2010. PT UNDERWENT REVISION SURGERY ON (B)(6), 2011 DUE TO UNEXPLAINED PAIN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD TIBIAL TRAY NRA BIOMET UK LTD. NA 1780940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R