BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 5822246 · Received July 26, 2016

    Report

    Report Number
    2520274-2016-13646
    Event Type
    Injury
    Date Received
    July 26, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ¿PROXIMAL FEMORAL NAIL ANTIROTATION (PFN-ATM) FIXATION OF EXTRA-CAPSULAR PROXIMAL FEMORAL FRACTURES IN THE ELDERLY: RETROSPECTIVE STUDY IN 102 FRACTURES MANAGED WITH PFN-A PATIENTS¿(2012) DE LANDEVOISIN, E. S., BERTANI, A., CANDONI, P., CHARPAIL , C., AND DEMORTIERE, E. ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH, 98, 288-295. THIS REPORT IS FOR AN UNKNOWN PROXIMAL FEMORAL NAIL ANTIROTATION/UNKNOWN QUANTITY/UNKNOWN LOT. UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: DE LANDEVOISIN, E. S., BERTANI, A., CANDONI, P., CHARPAIL , C., AND DEMORTIERE, E. (2012) PROXIMAL FEMORAL NAIL ANTIROTATION (PFN-A) FIXATION OF EXTRA-CAPSULAR PROXIMAL FEMORAL FRACTURES IN THE ELDERLY: RETROSPECTIVE STUDY IN 102 FRACTURES MANAGED WITH PFN-A PATIENTS. ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH, 98, 288-295. FRANCE. A (B)(6) STUDY REVIEWED PATIENTS THAT UNDERWENT PROXIMAL FEMORAL NAIL ANTIROTATION (PFN-A) (SYNTHES, (B)(4) IMPLANTATION FOR FIXATION, PERFORMED BETWEEN 2006 AND 2008 IN 102 PATIENTS (75 FEMALES AND 27 MALES) WITH A MEAN AGE 84.9 YEARS OF AGE. A (B)(6) MAN WITH ALCOHOL ABUSE REQUIRED REOPERATION FEMORAL DIAPHYSEAL FRACTURES UNDER THE NAIL. THE PATIENT WAS REVISED WITH A LONG PFN-A NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PFN-A. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475638 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention