BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-061891

    MDR report key: 3331104 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-061891
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ARTICLE CITATION : APRIL 2011. THIS REPORT IS FOR AN UNKNOWN NAIL. 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:FUNCTIONAL OUTCOME AFTER ANTEGRADE FEMORAL NAILING: A COMPARISON OF TROCHANTERIC FOSSA VERSUS TIP OF GREATER TROCHANTER ENTRY POINT. CHLOE ANSARI MOEIN, MD,HENK-JAN TEN DUIS, MD, PHD, LIAM OEY, MD, PHD, GERARD DE KORT, MD, WOUT VAN DER MEULEN, MD,S KARIN VERMEULEN, PHDK, AND CHRISTIAAN VAN DER WERKEN, MD, PHD.J ORTHOP TRAUMA 2011;25:196¿201. THE PROBLEM THAT OCCURRED FOR THE PATIENTS (IN BOTH GROUPS) DURING PROLONGED WALKING ALWAYS INCLUDED MUSCLE WEAKNESS AND SUBSEQUENT REDUCED ENDURANCE IN THE OPERATED LEG WITH ADDITIONAL LIMPING. ALL PATIENTS IN BOTH GROUPS HAD A HIP RANGE OF MOTION EQUAL TO THE OPPOSITE SIDE. THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT NUMBER (B)(4). A RETROSPECTIVE CLINICAL STUDY ON THE RELATIONSHIP BETWEEN ENTRY POINT-RELATED SOFT TISSUE DAMAGE IN ANTEGRADE FEMORAL NAILING AND THE FUNCTIONAL OUTCOME IN PATIENTS WITH A PROXIMAL THIRD FEMORAL SHAFT FRACTURE. THE STUDY INCLUDE SEVENTEEN MALE PATIENTS WITH A HIGH FEMORAL SHAFT FRACTURE TREATED WITH AN ANTEGRADE FEMORAL NAIL. A MALE PATIENT AGE (B)(6) WHO HAD AN UNREAMED FEMORAL NAIL PROCEDURE HAD A POSITIVE TRENDELENBURG SIGN AND A ABNORMAL EMG WITH EVIDENCE OF ACUTE INJURY TO THE SUPERIOR GLUTEAL NERVE AFTER THE OPERATION FOLLOWED BY REINNERVATION. THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443045 JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention