BEUDAMED
    FDA Adverse Event Death Summary report: N

    LCP PROXFEM HOOKPL 4.5/5 SHAFT 12HO L313

    MDR report key: 2685416 · Received August 2, 2012

    Report

    Report Number
    3003506883-2012-00213
    Event Type
    Death
    Date Received
    August 2, 2012
    Date of Event
    June 27, 2012
    Report Date
    July 5, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K032032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT. ALL PRODUCT RELEASED MET SPECIFICATION REQUIREMENTS DURING MANUFACTURING. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE IMPLANTS HAD TO ABSORB AND NEUTRALIZE FORCES OVER A LONG PERIOD OF TIME THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. THE SIZEABLE AREAS OF FORCED FRACTURE, DIMPLES, MIXED FRACTURE, AND THE FATIGUE CRACKS ARE A SIGN FOR VERY HIGH DYNAMIC LOADS. PROLONGED MECHANICAL STRESSING AND OVERLOAD DURING TO THE POSTOPERATIVE PERIOD LED TO THE FATIGUE OF THE MATERIAL AND CAUSED THE BREAKAGE OF THE IMPLANTS. POSTOPERATIVE ACTIVITIES OF THE PATIENT HAVE CERTAINLY PLAYED A ROLE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS OF BOTH IMPLANTS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT IMPLANTED WITH LCP PROXIMAL FEMORAL HOOK PLATE ON (B)(6) 2011. ON (B)(6) 2012, PATIENT WAS HAVING THE HARDWARE REMOVED; DURING SURGERY PATIENT DECOMPENSATED AND IT CAUSED CARDIAC ARREST. HE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND AFTER THREE DAYS HE DIED. INCIDENT HAS BEEN REPORTED TO (B)(4) ON JULY 03, 2012 BY SYNTHES (B)(4). FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP PROXFEM HOOKPL 4.5/5 SHAFT 12HO L313 LCP PROXFEM HOOKPLATE HRS SYNTHES ELMIRA 6324298

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| R