BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PHASE III FEMORAL COMPONENT

    MDR report key: 1000074 · Received February 18, 2008

    Report

    Report Number
    1825034-2008-00063
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    February 7, 2008
    Report Date
    January 22, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K011138
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. 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. THIS REPORT FILED ON FEBRUARY 18, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTICAL KNEE REPLACEMENT PROCEDURE IN 2003. SUBSEQUENTLY, RADIOGRAPHS INDICATE THAT ANTERIOR PORTION OF COMPONENT HAD FRACTURED. REVISION PROCEDURE WAS PERFORMED 2008. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD PHASE III FEMORAL COMPONENT HRY BIOMET, INC. NA 451060

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R