BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE TIBIAL TRAY

    MDR report key: 1083254 · Received July 30, 2008

    Report

    Report Number
    1825034-2008-00205
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE PROCEDURE 2006. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURE OF THE KNEE SECONDARY TO PAIN, LOOSENING AND DECREASED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE TIBIAL TRAY PROSTHESIS, KNEE COMPONENT NRA BIOMET UK LTD. N/A 930684

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R