BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP LAT FMRL 11.0M

    MDR report key: 3031766 · Received April 2, 2013

    Report

    Report Number
    0001825034-2013-00843
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    July 30, 2012
    Report Date
    March 8, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062994
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, AND/OR EXCESSIVE WEIGHT."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO STEM FRACTURE. THE STEM WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134204 TAPERLOC MICROP LAT FMRL 11.0M PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 294400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R