BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM

    MDR report key: 6921747 · Received October 6, 2017

    Report

    Report Number
    0001825034-2017-08085
    Event Type
    Injury
    Date Received
    October 6, 2017
    Report Date
    October 5, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PELT, C. E.; GILILLAND, J. M.; DOBLE,J; STRONACH, B. M.; PETERS, C. L. (2013) CLINICAL STUDY HYBRID TOTAL KNEE ARTHROPLASTY REVISITED: MIDTERM FOLLOWUP OF HYBRID VERSUS CEMENTED FIXATION IN TOTAL KNEE ARTHROPLASTY. HINDAWI PUBLISHING CORPORATION BIOMED RESEARCH INTERNATIONAL, VOLUME 2013, ARTICLE ID 854871, 6 PAGES; HTTP://DX.DOI.ORG/10.1155/2013/854871. ROOT CAUSE COULD NOT BE DETERMINED. CONDITION IS ADDRESSED IN THE PACKAGE INSERT. PART AND LOT IDENTIFICATION NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, AND COMPLAINT HISTORY WAS NOT PROVIDED. RISKS ASSOCIATED WITH REPORTED CONDITION ARE ADDRESSED THROUGH THE WARNINGS IN THE PACKAGE INSERT AS A PART OF DESIGN CONTROL RISK MANAGEMENT. ASSOCIATED PACKAGE INSERT (B)(4), THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR, UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER FIXATION. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "HYBRID TOTAL KNEE ARTHROPLASTY REVISITED: MIDTERM FOLLOWUP OF HYBRID VERSUS CEMENTED FIXATION IN TOTAL KNEE ARTHROPLASTY¿. THE ARTICLE IDENTIFIED SEVEN (7) REVISIONS OF EITHER THE TIBIAL OR FEMORAL COMPONENT WERE PERFORMED IN THE HYBRID TKAS GROUP FOR ASEPTIC CAUSES, AN UNIDENTIFIED NUMBER OF WHICH WERE PERFORMED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702297 VANGUARD COMPLETE KNEE SYSTEM PROSTHESIS - KNEE NRA ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R