BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5893047 · Received August 22, 2016

    Report

    Report Number
    2520274-2016-14266
    Event Type
    Injury
    Date Received
    August 22, 2016
    Report Date
    August 17, 2016
    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

    DATE OF EVENT: SCHUSTER, P. ET AL (2015). OPEN-WEDGE HIGH TIBIAL OSTEOTOMY AND COMBINED ABRASION/MICROFRACTURE IN SEVERE MEDIAL OSTEOARTHRITIS AND VARUS MALALIGNMENT: 5-YEAR RESULTS AND ARTHROSCOPIC FINDINGS AFTER 2 YEARS. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, 31, 1279-1288. THIS REPORT IS FOR AN UNKNOWN TOMOFIX SYSTEM / UNKNOWN QUANTITY / UNKNOWN LOT. ADDITIONAL DEVICE CODE: HWC. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, SCHUSTER, P. ET AL (2015). OPEN-WEDGE HIGH TIBIAL OSTEOTOMY AND COMBINED ABRASION/MICROFRACTURE IN SEVERE MEDIAL OSTEOARTHRITIS AND VARUS MALALIGNMENT: 5-YEAR RESULTS AND ARTHROSCOPIC FINDINGS AFTER 2 YEARS. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, 31, 1279-1288. THE AUTHORS CONDUCTED A PROSPECTIVE STUDY TO EXAMINE THE RESULTS OF MEDIAL OPEN-WEDGE HIGH TIBIAL OSTEOTOMY (HTO) COMBINED WITH A CHONDRAL RESURFACING PROCEDURE ABRASION/MICROFRACTURE) IN PATIENTS WITH GRADE 3 AND 4 OSTEOARTHRITIS WITH FULL-THICKNESS CARTILAGE DEFECTS AND VARUS MALALIGNMENT WHO WERE TREATED WITH SYNTHES TOMOFIX FIXATION. FROM SEPTEMBER 2005 TO DECEMBER 2008, 85 PATIENTS OR 91 CONSECUTIVE CASES (79 MALE AND 12 FEMALE WITH AN AVERAGE AGE OF 50.4 YEARS) UNDERWENT HTO IN COMBINATION WITH A CHONDRAL RESURFACING PROCEDURE. ONE PATIENT DIED AT TWO YEARS AND TEN PATIENTS DID NOT COMPLETE FOLLOW-UP. THEREFORE, 81 CASES WERE AVAILABLE FOR CLINICAL AND RADIOLOGIC EVALUATION POSTOPERATIVELY (MEAN FOLLOW-UP: 5.6 YEARS, RANGE 5.0 TO 7.3 YEARS). SERIOUS INJURY / REPORTABLE MALFUNCTION RESULTS INCLUDED SECONDARY DISLOCATION OF THE IMPLANT WITH SUBSEQUENT REVISION SURGERY AND REPOSITIONING. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TOMOFIX SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546361 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention