BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL SYS 8/15.0 SML ST

    MDR report key: 2840614 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-28048
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    LPH
    PMA / PMN Number
    K030979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIOUS INJURY IS UNLIKELY. NO HARM TO PATIENT, NO SIGNIFICANT DELAY.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. RADIOGRAPHIC INFORMATION WAS NOT AVAILABLE TO ASSIST THE INVESTIGATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES A PERIPROSTHETIC FRACTURE OF THE FEMORAL. DOI: (B)(6) 2012 DOR: NO REVISION (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOL SYS 8/15.0 SML ST STEM LPH DEPUY INTERNATIONAL E4NBF1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention