BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP

    MDR report key: 3220779 · Received July 11, 2013

    Report

    Report Number
    0001825034-2013-02630
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 FOR UNKNOWN REASONS. IN ADDITION, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO A FALL WHICH CAUSED THE PATIENT¿S FEMUR TO FRACTURE. DURING THE PROCEDURE THE HEAD, POLYETHYLENE LINER, AND STEM COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320245 UNK HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R