BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ROM STEM BODY TRIAL 16

    MDR report key: 1231061 · Received October 29, 2008

    Report

    Report Number
    1818910-2008-05032
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    TOTAL HIP ARTHROPLASTY WAS DONE WITH S-ROM. IT WAS NOTED BY THE X-RAY IMMEDIATELY AFTER THE SURGERY THAT A STEM TRIAL REMAINED IN THE PT'S BODY. INSTANTLY, ANOTHER SURGERY WAS DONE TO REMOVE THE STEM TRIAL. ACCORDING TO THE DOCTOR, DURING INSERTION, THE STEM TRIAL BECAME UNCOUPLED FROM THE TRIAL BODY IN THE FEMORAL MEDULLARY SPACE. THE OPERATION TIME EXTENDED FOR ABOUT 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM STEM BODY TRIAL 16 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA AH1107

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR