BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3813614 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11229
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. EL-AZAB, H. M., MORGENSTERN, M., AHRENS, P., SCHUSTER, T., IMHOFF, A. B., & LORENZ, S. G. F. (2011). LIMB ALIGNMENT AFTER OPEN-WEDGE HIGH TIBIAL OSTEOTOMY AND ITS EFFECT ON THE CLINICAL OUTCOME. ORTHOPEDICS, 34(10), 622-628. THIS REPORT IS FOR AN UNKNOWN PLATE. 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. EL-AZAB, H. M., MORGENSTERN, M., AHRENS, P., SCHUSTER, T., IMHOFF, A. B., & LORENZ, S. G. F. (2011). LIMB ALIGNMENT AFTER OPEN-WEDGE HIGH TIBIAL OSTEOTOMY AND ITS EFFECT ON THE CLINICAL OUTCOME. ORTHOPEDICS, 34(10), 622-628. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE ACCURACY OF ALIGNMENT AFTER OPEN-WEDGE HIGH TIBIAL OSTEOTOMY AND ITS EFFECT ON THE CLINICAL OUTCOME. FROM SEPTEMBER 2006 TO APRIL 2007, A PROSPECTIVE CASE SERIES OF 56 CONSECUTIVE PATIENTS WITH VARUS OSTEOARTHRITIS UNDERWENT OPEN-WEDGE HIGH TIBIAL OSTEOTOMY FIXED WITH A TOMOFIX PLATE FIXATOR (SYNTHES, WEST CHESTER, PENNSYLVANIA). THE CORRECTION ANGLE WAS RADIOLOGICALLY DETERMINED PREOPERATIVELY AND AT 6 MONTHS POSTOPERATIVELY. THE PATIENTS WERE CLINICALLY AND RADIOLOGICALLY EXAMINED PREOPERATIVELY AND AT 3, 6, AND 36 MONTHS POSTOPERATIVELY. ONE PATIENT SUFFERED A FALL ON ICE, RESULTING IN BREAKAGE OF THE PLATE AND DISPLACEMENT OF THE OSTEOTOMY 3 MONTHS POSTOPERATIVELY. A REVISION OPERATION WAS PERFORMED SUCCESSFULLY. THE SECOND PATIENT REPORTED PAIN IN THE WHOLE BODY, GASTROINTESTINAL PAIN, SWELLING IN MULTIPLE AREAS OF THE BODY, AND SLEEP PROBLEMS 6 MONTHS POSTOPERATIVELY. THE DIAGNOSIS OF FIBROMYALGIA WAS MADE. THERE WERE 3 PATIENTS WITH RELATIVELY DELAYED HEALING AND 3 PATIENTS WHO WERE NOT SATISFIED RESULTS. TEN PATIENTS REQUIRED OCCASIONAL PAIN MEDICATION AND 2 REQUIRED REGULAR PAIN MEDICATION. OPEN-WEDGE HIGH TIBIAL OSTEOTOMY RESULTS IN SIGNIFICANT IMPROVEMENT OF SYMPTOMS AND FUNCTION IN ALL PATIENTS IN THE SHORT TERM, EVEN WITH UNDER- AND OVERCORRECTION OF THE OSTEOTOMY. UNDERCORRECTION WAS ASSOCIATED WITH A SIGNIFICANTLY LOWER CLINICAL OUTCOME IN COMPARISON TO THE ACCURATE CORRECTION AND OVERCORRECTION. LIGAMENTOUS LAXITY OR SOFT TISSUE SLACKNESS OF THE KNEE CAN INFLUENCE THE OVERALL CORRECTION AFTER HIGH TIBIAL OSTEOTOMY AND MUST BE CONSIDERED IN PREOPERATIVE PLANNING. PATIENTS WITH A HIGH BODY MASS INDEX HAD INFERIOR CLINICAL RESULTS AFTER OPEN-WEDGE HIGH TIBIAL OSTEOTOMY. THIS REPORT IS FOR 1 DEVICE. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. ONE OF 2 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290715 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention