BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6570258 · Received May 16, 2017

    Report

    Report Number
    2520274-2017-11645
    Event Type
    Injury
    Date Received
    May 16, 2017
    Report Date
    April 19, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. JANG, J.H., AHN, J.M., LEE, H.J., AND MOON, N. H. (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, UNKNOWN QUANTITY, UNKNOWN LOT. COMMON DEVICE NAME: HWC. OTHER NUMBER: UDI: 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. 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

    LITERATURE ARTICLES RECEIVED: THIS ARTICLE IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, JANG, J.H., AHN, J.M., LEE, H.J., AND MOON, N. H. (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, WERE ENROLLED. THE LESS INVASIVE STABILIZATION SYSTEM-DISTAL FEMUR (LISSDF; SYNTHES, (B)(4)) AND THE NEWLY DESIGNED LOCKING COMPRESSION PLATE-DISTAL FEMUR (LCP-DF, SYNTHES) WERE USED. 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. A (B)(6) PATIENT EXPERIENCED NONUNION WITH IMPLANT BREAKAGE, SLIGHT LATERAL DISPLACEMENT OF THE PROXIMAL FRAGMENT. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR A UNKNOWN LCP-DF, SYNTHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349965 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention