BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK VANGUARD

    MDR report key: 6926410 · Received October 7, 2017

    Report

    Report Number
    0001825034-2017-08078
    Event Type
    Injury
    Date Received
    October 7, 2017
    Report Date
    October 6, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT- (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. VOLUME NUMBER(ISSUE NUMBER), PAGES. J., DOBLE, PELT, C., GILILLAND, J., STRONACH, B., PETERS, C. (2013). HYBRID TOTAL KNEE ARTHROPLASTY REVISITED: MIDTERM FOLLOWUP OF HYBRID VERSUS CEMENTED FIXATION IN TOTAL KNEE ARTHROPLASTY. BIOMED RESEARCH INTERNATIONAL, VOL. 2013, 6 PAGES. HTTP://DX.DOI.ORG/10.1155/2013/854871.

    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 FIVE (5) REVISIONS OF EITHER THE TIBIAL OR FEMORAL COMPONENT WERE PERFORMED IN THE CEMENTED TKAS GROUP FOR ASEPTIC CAUSES, AN UNIDENTIFIED NUMBER OF WHICH WERE PERFORMED DUE TO MALALIGNMENT RELATED COMPLICATIONS IN TOTAL OF 111 CEMENTED TKAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706572 UNK VANGUARD PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R