BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6552272 · Received May 8, 2017

    Report

    Report Number
    2520274-2017-11609
    Event Type
    Injury
    Date Received
    May 8, 2017
    Report Date
    April 11, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. JANG, J; AHN, J; LEE, H; MOON, N (2017) SURGICAL OUTCOMES OF BIOLOGIC FIXATION FOR SUBTROCHANTERIC FRACTURE USING LOCKING COMPRESSION PLATES. HIP & PELVIS 29:1, 68-76. THIS REPORT IS FOR UNKNOWN LOCKING COMPRESSION PLATE-DISTAL FEMUR, UNKNOWN QUANTITY, UNKNOWN LOT. 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. 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 REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: JANG, J; AHN, J; LEE, H; MOON, N (2017) SURGICAL OUTCOMES OF BIOLOGIC FIXATION FOR SUBTROCHANTERIC FRACTURE USING LOCKING COMPRESSION PLATES. HIP & PELVIS 29:1, 68-76. THIS STUDY AIMED TO EVALUATE THE SURGICAL OUTCOMES OF BIOLOGIC PLATING USING LOCKING COMPRESSION PLATE-DISTAL FEMUR (LCP-DF) IN PATIENTS WITH SUBTROCHANTERIC FRACTURE OF THE FEMUR. BETWEEN JANUARY 2010 AND DECEMBER 2013, 28 CONSECUTIVE PATIENTS WITH SUBTROCHANTERIC FRACTURES OF THE FEMUR, TREATED WITH BIOLOGIC FIXATION USING (LCP-DF SYNTHES), WERE ENROLLED. THE PRESENT STUDY INCLUDED 19 MALES AND 9 FEMALES. THE MEAN AGE WAS 58.7 YEARS (RANGE, 24-85 YEARS). THE RIGHT FEMUR WAS INVOLVED IN 15 PATIENTS AND THE LEFT FEMUR WAS INVOLVED IN 13 PATIENTS. ALL PATIENTS WERE FOLLOWED-UP AT 1, 3, 6, AND 12 MONTHS, AND THEN ANNUALLY AFTER PRIMARY SURGERY FOR CLINICAL AND RADIOGRAPHIC EVALUATIONS OF THE FRACTURE HEALING PROCESS. THERE WAS 1 CASE OF NONUNION WITH IMPLANT BREAKAGE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LCP-DF. THIS REPORT IS FOR A (B)(6) WHO EXPERIENCED NONUNION, PLATE BREAKAGE AND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332438 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention