BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TIB BRG LG SZ9

    MDR report key: 2810083 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02267
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    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. 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. DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2012 DUE TO DISLOCATION. THE BEARING COMPONENT WAS REMOVED AND REPLACED WITH THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNI TIB BRG LG SZ9 PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A 825813

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R