BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4220321 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14192
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. OPENING WEDGE DISTAL FEMORAL VARUS OSTEOTOMY FOR LATERAL COMPARTMENT OSTEOARTHRITIS IN THE VALGUS KNEE. SAITHNA A., KUNDRA R., GETGOOD A., SPALDING T. THE KNEE 21 (2014) 172-175. THIS REPORT IS FOR UNKNOWN TOMOFIX PLATE. (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NOT CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. 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 JOURNAL ARTICLE, OPENING WEDGE DISTAL FEMORAL VARUS OSTEOTOMY FOR LATERAL COMPARTMENT OSTEOARTHRITIS IN THE VALGUS KNEE. SAITHNA A., KUNDRA R., GETGOOD A., SPALDING T. THE KNEE 21 (2014) 172-175 THIS STUDY REPORTS THE RESULTS OF A CASE SERIES OF OPENING WEDGE DISTAL FEMORAL VARUS OSTEOTOMIES FOR VALGUS LATERAL OSTEOARTHRITIS OF THE KNEE. EIGHTEEN PATIENTS UNDERWENT OSTEOTOMY SURGERY (21 KNEES) WITH THE AIM OF CORRECTING THE MECHANICAL AXIS TO 48-50% FROM MEDIAL TO LATERAL. COMPLICATIONS: FOUR PATIENTS REQUIRED RE-OPERATION DID SO FOR THE FOLLOWING: 2 LOSS OF CORRECTION, 1 PLATE MAL-POSITION IN THE PRESENCE OF INFECTION AND 1 NON-UNION. COMPLICATIONS: 10 PATIENTS UNDERWENT REMOVAL OF METALWORK DUE TO LOCALIZED DISCOMFORT OR TENDERNESS. IT IS UNCLEAR IS THESE PATIENTS WERE TREATED WITH SYNTHES OR A COMPLETIVE PLATE. THIS REPORT IS FOR AN UNKNOWN-TOMOFIX PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703685 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention