BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM MD PMA

    MDR report key: 3734447 · Received April 8, 2014

    Report

    Report Number
    0001825034-2014-02572
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 4, 2016
    Manufacturer
    BIOMET U.K. LTD
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF THE DEVICE FOUND THE CEMENT TECHNIQUE APPLIED TO THE FEMORAL COMPONENT WAS NOT FOLLOWED PROPERLY BY NOT HAVING A SMOOTH TRANSITION ON APPLIED CEMENT AND DEVICE. ADDITIONAL CEMENT WAS OBSERVED OUTSIDE THE BOUNDARIES OF THE PART WHICH CAN RESULT IN POOR FIXATION. THIS CAN CAUSE FAILURE THE DEVICE TO FAIL AND LEAD TO DISCOMFORT TO THE PATIENT.

    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. PRODUCT IS BEING RETURNED TO MANUFACTURER, BUT HAS NOT YET BEEN RECEIVED BY MANUFACTURER. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02571 / 02572).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 10 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY (B)(6) 2013. SUBSEQUENTLY IT WAS REPORTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO HARDWARE FAILURE. THE BEARING AND FEMORAL COMPONENT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO FEMORAL LOOSENING. THE FEMORAL COMPONENT AND TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210514 OXF TWIN-PEG CMNTD FEM MD PMA PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A 991740

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R