BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06219

    MDR report key: 3329653 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-06219
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PUBLICATION DATE: MARCH 10 2004, REVISED: JANUARY 2, 2005. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: CAN THE PROXIMAL FEMORAL NAIL BE IMPROVED AUTHORS: SCHIPPER I.B., SIMMERMACHER R.K.J., HUTTL T., FRIGG R., MESSMER P., SCHUTZ M., LENICH A., VAN DER WERKEN C. EUROPEAN JOURNAL OF TRAUMA. 2005; 31 (3) :258-265. THIS ARTICLE REPORTS A MULTICENTER OBSERVATIONAL STUDY OF 245 PATIENTS WITH A MEAN AGE OF 75 DIAGNOSED WITH UNSTABLE TROCHANTERIC FRACTURES WHICH WERE TREATED WITH MODIFIED PROXIMAL FEMORAL NAIL. SUBSEQUENTLY, PATIENT ADVERSE EVENTS INCLUDED POSTOPERATIVE WOUND PROBLEMS, DISLOCATION OF PROXIMAL SCREWS, PSEUDARTHROSIS, HARDWARE REMOVAL AND/OR REPLACEMENT. IT IS UNKNOWN IF SYNTHES DEVICE(S) CONTRIBUTED TO THE ADVERSE EVENTS. THIS COMPLAINT REPRESENTS POSTOPERATIVE WOUND PROBLEMS, INCLUDING SUPERFICIAL WOUND INFECTION, DEEP WOUND INFECTION, AND HEMATOMA IN 20 PATIENTS IN THE STUDY. TWO REINTERVENTIONS TOOK PLACE DUE TO WOUND-RELATED PROBLEMS. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4). THIS REPORT IS FOR THE UNKNOWN DISTAL SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444520 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention