BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI FEMORAL MD

    MDR report key: 3091271 · Received May 3, 2013

    Report

    Report Number
    0001825034-2013-01254
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 30, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE IMPLANTED - UNKNOWN. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-01254 / 01256).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT PARTIAL KNEE PROCEDURE IN 2007. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2013 DUE TO INFECTION. THE FEMORAL, BEARING AND TIBIAL TRAY WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194054 OXFORD UNI FEMORAL MD PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A 1361775

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R