BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ B LM PMA

    MDR report key: 3936178 · Received July 15, 2014

    Report

    Report Number
    0001825034-2014-06192
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 12, 2014
    Report Date
    March 10, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. DISCARDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT (B)(6).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 1 STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6), 2014. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2014 DUE TO MALPOSITIONING. THE TIBIAL BEARING AND TIBIAL TRAY WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412192 OXF UNI TIB TRAY SZ B LM PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 857140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R