BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ D RM PMA

    MDR report key: 4821861 · Received June 5, 2015

    Report

    Report Number
    0001825034-2015-02447
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 11, 2015
    Report Date
    March 2, 2016
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECTED INFORMATION AND TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REQUESTED BUT NOT RETURNED BY HOSPITAL.

    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 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2015-02446).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION: CORRECTED DATA: PATIENT SEX - FEMALE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT UNDERWENT A BEARING EXCHANGE ON (B)(6) 2014 DUE TO UNKNOWN REASONS. ON (B)(6) 2015, PATIENT WAS REVISED TO A TOTAL KNEE DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365451 OXF UNI TIB TRAY SZ D RM PMA PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 2487607

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R