BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODIGY LG STAT LNG LT 15.0MM

    MDR report key: 1080226 · Received July 18, 2008

    Report

    Report Number
    1818910-2008-02636
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 18, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000207
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    DURING THE PRIMARY SURGERY, THE SURGEON FELT THAT THE STEM BEING USED WAS UNDERSIZED. THE SURGERY WAS DELAYED APPROXIMATELY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODIGY LG STAT LNG LT 15.0MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA AH6F6A000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA