BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM LEFT MEDIAL TIBIAL TRAY SZ A

    MDR report key: 2222215 · Received August 24, 2011

    Report

    Report Number
    1825034-2011-00750
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    May 18, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 DUE TO TIBIAL LOOSENING. THE PATIENT WAS REVISED TO A TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD PARTIAL KNEE SYSTEM LEFT MEDIAL TIBIAL TRAY SZ A PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 042859

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R