BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSARIES

    MDR report key: 5591842 · Received April 20, 2016

    Report

    Report Number
    2520274-2016-12152
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    August 31, 2011
    Report Date
    April 4, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(6). (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, HARVEY, NORAH, M.D, AND ET AL. (2011). "ENDOPROSTHESES LAST LONGER THAN INTRAMEDULLARY DEVICES IN PROXIMAL FEMUR METASTASES." CLINICAL ORTHOPAEDICS AND RELATED RESEARCH (2012) 470: 684-691 UNITED STATES ARTICLE. THE ARTICLE WAS BASED ON A RETROSPECTIVE STUDY OF 158 PATIENTS WITH 159 PROXIMAL FEMUR METASTATIC LESIONS TREATED WITH SURGICAL STABILIZATION. FORTY-SIX (46) WERE TREATED WITH SYNTHES AND TRIGEN INTRAMEDULLARY FIXATION (IMN) AND 113 WERE TREATED WITH ENDOPROSTHETIC RECONSTRUCTION (EPR). THE STUDY DID NOT DIFFERENTIATE BETWEEN SYNTHES AND COMPETITOR PRODUCTS IN REGARD TO COMPLICATIONS. THE GOAL OF THE STUDY WAS TO DETERMINE WHETHER IMN OR EPR WAS MORE SUCCESSFUL IN TREATING METASTATIC LESIONS TO THE SKELETON. THE FOLLOWING COMPLICATIONS OF THE IMN WERE NOTED; EACH WAS NOTED WITH SPECIFIC PATIENT INFORMATION: INFECTION WITH NO PRODUCT ALLEGATION; RESULTED IN AMPUTATION (HIP DISARTICULATION) (1 PATIENT) THIS IS REPORT 15 OF 17 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN NAIL A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243017 ROD, FIXATION, INTRAMEDULLARY AND ACCESSARIES HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention