BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKOWN DEPUY SOLUTION STEM TRIAL

    MDR report key: 1973466 · Received January 14, 2011

    Report

    Report Number
    1818910-2011-00615
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT REVISED FOR FEMORAL PAIN, OSTEOLYSIS, POLYETHYLENE WEAR AND LOOSE FEMORAL COMPONENT. DURING IMPACTION OF STEM TRIAL BONE FX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKOWN DEPUY SOLUTION STEM TRIAL 87 LXH LXH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR