BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML 12.0 STD 6.3 5/8 STD 12/14

    MDR report key: 4153016 · Received October 8, 2014

    Report

    Report Number
    1818910-2014-29628
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    March 13, 2013
    Report Date
    January 14, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK953694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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. (B)(4).

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. THE CLAIM ALLEGED A FAILED AML STEM. THE MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY AND THEY CONFIRMED PAIN, FRACTURED LEFT FEMORAL COMPONENT, AND LOOSE STEM PROXIMALLY. IT SHOULD ALSO BE NOTED THAT THE POLY LINER WAS CHANGED DUE TO BEING IMPLANTED 10 YEARS, BUT THERE WAS NO MENTION OF POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631491 AML 12.0 STD 6.3 5/8 STD 12/14 HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS, INC. VJ4BH1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention