BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FEMORAL NC 14X150

    MDR report key: 3103168 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01353
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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, OR EXCESSIVE ACTIVITY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT FELL MULTIPLE TIMES AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO THE STEM SUBSIDING. THE FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204203 ECHO POR FEMORAL NC 14X150 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 047140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R