BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL STEM

    MDR report key: 3892866 · Received June 24, 2014

    Report

    Report Number
    1818910-2014-21852
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    August 18, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF DEVICE HISTORY RECORDS AND/OR A SEARCH OF THE COMPLAINTS DATABASES WAS NOT POSSIBLE AS THE NECESSARY PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE ARTIFICIAL HIP/STEM FAILED ON (B)(6) 2010, CAUSING THE PATIENT TO FALL, RESULTING IN PAIN AND INJURIES TO THE PATIENT'S HEAD, NECK, BACK, ARMS, BODY, LIMBS, ORGANS AND SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369250 UNKNOWN DEPUY FEMORAL STEM FEMORAL STEM KXA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other