BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06210

    MDR report key: 3328694 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-06210
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES, USA
    Product Code
    HRS
    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. 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

    JOURNAL ARTICLE RECEIVED: THE PROXIMAL FEMUR NAIL ANTIROTATION: AN IDENTIFIABLE IMPROVEMENT IN THE TREATMENT OF UNSTABLE PERTROCHANTERIC FRACTURES?; GARDENBROEK TJ, SEGERS MJ, SIMMERMACHER RK, HAMMACHER ER.; JOURNAL OF TRAUMA-INJURY INFECTION & CRITICAL CARE. 2011 JUL; 71(1):169-74; REPORTED: A COMPARATIVE STUDY OF THE EFFECTS OF TREATMENT WITH EITHER SYNTHES DEVICES, THE PROXIMAL FEMUR NAIL (PFN) OR THE PROXIMAL FEMUR NAIL ANTIROTATION (PFNA), FOR UNSTABLE TROCHANTERIC FRACTURES. THE PFN GROUP WAS COMPRISED OF 87 PATIENTS WITH A MEAN AGE OF 79.1 YEARS; THE PFNA GROUP WAS COMPRISED OF 70 PATIENTS WITH A MEAN AGE 79.8 YEARS. BOTH GROUPS WERE PREDOMINATELY WOMEN. THE AUTHORS REPORTED RESULTS AS FOLLOWS. POSTOPERATIVE URINARY TRACT INFECTIONS AND PNEUMONIA WERE NOTED IN 47 PATIENTS IN THE PFN GROUP; UNSPECIFIED POSTOPERATIVE SYSTEMIC COMPLICATIONS IN 35 PATIENTS WERE NOTED IN THE PFNA GROUP. IN THE PFN GROUP, FIVE PATIENTS DEVELOPED POSTOPERATIVE LOCAL COMPLICATIONS VERSUS THREE PATIENTS IN THE PFNA GROUP. THE AUTHORS NOTED THESE COMPLICATIONS AS INFECTED HEMATOMA AND WOUND INFECTION NECESSITATING EARLY REOPERATION. IMPLANT RELATED COMPLICATIONS REPORTED AS MIGRATION OR MALPOSITION NECESSITATED EARLY REOPERATION IN THREE PFN PATIENTS AND FOUR PFNA PATIENTS. LATE REOPERATION DUE TO NONUNION OF THE FRACTURE PARTS, DISCOMFORT OR SECONDARY DISLOCATION OF THE FEMORAL HEAD OR NECK IMPLANT WAS REPORTED IN 13 PFN PATIENTS AND THREE PFNA PATIENTS. PRODUCTS REPORTED WERE SYNTHES DEVICES. THIS IS 1 OF 8 REPORTS FOR UNKNOWN PFN NAIL FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445039 HRS SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention