BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL SYS 8/12.0 LRG ST

    MDR report key: 3761310 · Received April 21, 2014

    Report

    Report Number
    1818910-2014-17159
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    October 1, 2008
    Report Date
    April 1, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK060581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL REPORT STATES THAT PATIENT SUSTAINED AN INTRAOPERATIVE FEMORAL SHAFT FRACTURE, WHICH WAS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION. DOI: UNKNOWN DOR: UNKNOWN (HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT SUSTAINED AN INTRAOPERATIVE FEMORAL SHAFT FRACTURE, WHICH WAS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239895 SOL SYS 8/12.0 LRG ST HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention