BEUDAMED
    FDA Adverse Event Death Summary report: N

    LCP PROX-FEM PI 4.5/5 LE SHAFT 14HO L355

    MDR report key: 2633729 · Received June 21, 2012

    Report

    Report Number
    8030965-2012-00403
    Event Type
    Death
    Date Received
    June 21, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED

    Description of Event or Problem · 1

    (B)(6) STUDY: IN THIS SURGERY, THE MEDIAL SUPPORT OF THE PF-LCP WAS ACHIEVED BY USING CERCLAGE CABLE. THE TROCHANTER MINOR COULD BE ANATOMICALLY REDUCED BUT A SHORT TIME AFTER THE SURGERY, A SECONDARY DISLOCATION OF THE TROCHANTER MINOR WAS NOTICED. AS A RESULT THE PROXIMAL SCREW BROKE RESULTING IN LOSS OF REDUCTION. ON (B)(6) 2012, THE PT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL AND IMPLANTATION OF LARGER PLATE. THE PT DIED POSTOPERATIVE FROM CARDIAC ARREST. THIS REPORT IS #2 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP PROX-FEM PI 4.5/5 LE SHAFT 14HO L355 LCP PROX-FEM PI 4.5/5 LE SHAFT 14HO L355 HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death SCREW