BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMROCK DISTAL FEMORAL EXP 180MM LEFT

    MDR report key: 3052120 · Received April 11, 2013

    Report

    Report Number
    0001825034-2013-00927
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 16, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "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 EVENT (REFERENCE 1825034-2013-00320-1 & 00927).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT PATIENT MATCHED IMPLANT AND ORTHOPEDIC SALVAGE SYSTEM PROCEDURE ON (B)(6) 1999. SUBSEQUENTLY, RADIOGRAPHS TAKEN CONFIRMED THAT THE TIBIAL TRAY WAS LOOSE AND PATIENT WAS REVISED ON (B)(6) 2013 DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154716 AMROCK DISTAL FEMORAL EXP 180MM LEFT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 024070

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R