BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE SMALL

    MDR report key: 2210726 · Received August 12, 2011

    Report

    Report Number
    1825034-2011-00710
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    August 11, 2009
    Report Date
    July 18, 2011
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2011-00710 & 00711). THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6), 2007. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2009 DUE TO LOOSENING. ALL COMPONENTS WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE SMALL PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 382251

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R