BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK STEM TIB TRAY 71MM

    MDR report key: 6191377 · Received December 20, 2016

    Report

    Report Number
    0001825034-2016-05329
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 21, 2016
    Report Date
    February 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WAS RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. REVIEW OF DEVICE HISTORY RECORDS FOUND NO DEVIATION DURING THE MANUFACTURING PROCESS. THIS DEVICE IS USED FOR TREATMENT. ROOT CAUSE WAS DUE TO PATIENT EXPERIENCING OUTSIDE TRAUMA FROM A CAR ACCIDENT. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: VANGUARD LEFT TITANIUM FEMUR 60MM CATALOG CP113615 LOT 701620; VANGUARD CRUCIATE RETAINING BEARING CATALOG 183546 LOT 722650. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2015-03725 / 1825034-2015-03726 / 1825034-2016-05328 / 1825034-2016-05329).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO LOOSENING CAUSED BY TRAUMA EXPERIENCED BY THE PATIENT. THE BEARING, FEMORAL, AND TIBIAL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841163 BIOMET ILOK STEM TIB TRAY 71MM BIOMET STEMMED TIBIAL TRAY WITH LOCKING BAR & PLUGS 71MM - INTERLOK JWH BIOMET ORTHOPEDICS N/A 048510

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R