BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANATOMIC BEARING

    MDR report key: 2051048 · Received April 4, 2011

    Report

    Report Number
    3002806535-2011-00044
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    January 14, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P0100014
    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)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6), 2006. PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2011 DUE TO PAIN FROM PROGRESSION OF LATERAL COMPARTMENT DISEASE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD ANATOMIC BEARING NRA BIOMET UK LTD. NA 1116982

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R