BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3813258 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11218
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 25, 2014
    Manufacturer
    DEPUY SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EHLINGER, M. ET AL. (2011). TREATMENT OF PERIPROSTHETIC FEMORAL FRACTURES OF THE KNEE. KNEE SURG SPORTS TRAUMATOL ARTHROSC, 19, 1473-1478. THIS REPORT IS FOR AN UNKNOWN LISS PLATE. 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 REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: EHLINGER, M. ET AL. (2011). TREATMENT OF PERIPROSTHETIC FEMORAL FRACTURES OF THE KNEE. KNEE SURG SPORTS TRAUMATOL ARTHROSC, 19, 1473-1478. THE AUTHORS CONDUCTED A RETROSPECTIVE STUDY FROM JUNE 2002 TO DECEMBER 2008 OF 16 PATIENTS, 15 WOMEN AND ONE MAN, WITH 16 PERIPROSTHETIC FEMORAL FRACTURES AFTER KNEE ARTHROPLASTY TREATED WITH SYNTHES DEVICE, LESS INVASIVE STABILIZATION SYSTEM (LCP) PLATE. PATIENTS UNDERWENT MINIMALLY INVASIVE SURGERY AND IMMEDIATE WEIGHT-BEARING AFTER SURGERY WHICH THE AUTHORS HYPOTHESIZED WOULD IMPROVE THEIR FUNCTIONAL RECOVERY. MEDIAN PATIENT AGE WAS 81 YEARS WITH MEDIAN BODY MASS INDEX OF 29 (RANGE 21-40). AVERAGE TIME BETWEEN ARTHROPLASTY AND FRACTURE WAS 8.7 YEARS (RANGE 2-16). RESULTS SHOWED RADIOLOGICAL CONSOLIDATION IN ALL BUT ONE PATIENT. NONUNION WAS NOT TREATED BECAUSE IT WAS WELL TOLERATED AND BECAUSE OF THE CRITICAL CARDIOVASCULAR HISTORY OF THE PATIENT. RANGE OF MOTION WAS ZERO TO 60 DEGREES. THE AUTHORS CONCLUDED THAT LOCKING PLATES ARE WELL ADAPTED TO PERIPROSTHETIC FEMUR FRACTURES ACCORDING TO THE RESULTS OF THEIR STUDY. THIS REPORT IS FOR AN UNKNOWN LISS PLATE. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290944 PLATE, FIXATION, BONE HRS DEPUY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention