BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX BIOMET PRIMARY TIBIAL TRAY 79MM

    MDR report key: 2132777 · Received June 17, 2011

    Report

    Report Number
    1825034-2011-00511
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    K080361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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: UNDER WARNINGS, IT 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". THIS REPORT SUBMITTED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2011. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO MALALIGNMENT. THE TIBIAL TRAY WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGENEREX BIOMET PRIMARY TIBIAL TRAY 79MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 295330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R