BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD FEMORAL KNEE

    MDR report key: 2031604 · Received March 23, 2011

    Report

    Report Number
    3002806535-2011-00031
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 21, 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. 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)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6), 2001. PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2011 DUE TO PATELLA 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 452298

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R