BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04648

    MDR report key: 3310783 · Received August 27, 2013

    Report

    Report Number
    2520274-2013-04648
    Event Type
    Injury
    Date Received
    August 27, 2013
    Report Date
    July 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF REPORT: 2002 ; 122 (1) :61-63. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: NO SUSPECTED ASSOCIATION BETWEEN DEATH AND THE USE OF THE PRODUCT. CORRECTION TO OUTCOMES ATTRIBUTED TO ADVERSE EVENT FROM DEATH AND REQUIRED INTERVENTION TO OTHER SERIOUS. TYPE OF REPORTABLE EVENT WAS CORRECTED FROM DEATH TO SERIOUS INJURY.

    Description of Event or Problem · 1

    AN ABSTRACT WAS RECEIVED: FATAL RETROPERITONEAL HEMORRHAGE CAUSED BY PERFORATION OF A GUIDEWIRE PIN FOR PROXIMAL FEMUR FIXATION; ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY. 2002 ; 122 (1) :61-63. AUTHORS: LEUNIG M., MEYER M., BECK M., TRILLER J., STUPNICKI A., ZIMMERMANN H. THE ABSTRACT REPORTS: PATIENT PRESENTED WITH A SLIGHTLY DISPLACED INTERTROCHANTERIC TWO-FRAGMENT FRACTURE OF THE LEFT HIP WAS IMPLANTED WITH INTERNAL FIXATION WITH A SCREW-NAIL DEVICE (GAMMA NAIL). POST-OPERATIVELY THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. A LARGE RETROPERITONEAL FLUID ACCUMULATION IN THE PATIENTS LEFT LOWER ABDOMEN WAS NOTED ON AN ULTRASOUND TAKEN. ACTIVE HEMORRHAGE NEXT TO THE PATIENTS QUADRILATERAL SURFACE OF THE LEFT ACETABULUM WAS NOTED ON THE CONTRAST COMPUTED TOMOGRAM. THE BLEEDING WAS STOPPED WITH SELECTIVE ANGIOGRAPHY AND EMBOLIZATION. THE PATIENT THEN DEVELOPED AN OLIGOSYMPTOMATIC MYOCARDIAL INFARCTION ASSOCIATED WITH CLINICAL EVIDENCE OF A CEREBROVASCULAR INSULT AND PULMONARY DECOMPENSATION; CONSEQUENTLY THE PATIENT DIED TWO WEEKS AFTERWARDS. REPORTEDLY THE CAUSE OF THE PATIENTS HEMORRHAGE WAS MOST LIKELY DUE TO SURGICAL DAMAGE TO THE PATIENTS OBTURATOR ARTERY. DURING THE PROCEDURE, THE GUIDE WIRE PIN (WITH THREADED TIP) WAS PLACED TO POSITION THE SCREW OF THE IMPLANT. IT IS UNKNOWN IF THE GUIDE WIRE PIN ASSOCIATED WITH THIS EVENT WAS A SYNTHES PRODUCT. THIS REPORT IS FOR A GUIDE WIRE PIN. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419525 LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| O| R