BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY LPS FEMORAL HIP PROSTHESIS

    MDR report key: 1190208 · Received October 6, 2008

    Report

    Report Number
    MW5008549
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 6, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY WITH A DEPUY LPS PC PROSTHESIS INSERTED. THE PT HAD RECURRENT DISLOCATIONS POST SURGERY REQUIRING A CLOSED REDUCTION ABOUT FOUR DAYS LATER, AND THEN A COMPLETE REDO AT APPROXIMATELY TWO WEEKS LATER. UPON EVALUATION OF THE FEMORAL STEM, THE MODULAR COMPONENTS WERE COLD-WELDED TOGETHER, AND COULD NOT BE UNLOCKED AND THE WHOLE COMPONENT APPEARED TO HAVE ROTATIONAL INSTABILITY REQUIRING INSERTION OF A NEW PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY LPS FEMORAL HIP PROSTHESIS TOTAL HIP PROSTHESIS/INSTRUMENT JDI DEPUY ORTHOPAEDICS, INC. 128712-205 BW38F1
    2 DEPUY LPS FEMORAL HIP PROSTHESIS TOTAL HIP PROSTHESIS/INSTRUMENT JDI DEPUY ORTHOPAEDICS, INC. CJ6DV1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization