BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK VANGUARD KNEE

    MDR report key: 7052178 · Received November 22, 2017

    Report

    Report Number
    0001825034-2017-10483
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    November 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT- (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. PELT, C. "HYBRID TOTAL KNEE ARTHROPLASTY REVISITED: MIDTERM FOLLOW-UP OF HYBRID VERSUS CEMENTED FIXATION IN TOTAL KNEE ARTHROPLASTY" (2013). BIOMED RESEARCH INTERNATIONAL, VOL, 13, ARTICLE ID 854871, 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 ONE (1) KNEE WAS REVISED FOR ISOLATED ASEPTIC LOOSENING OF THE FEMORAL COMPONENT IN THE HYBRID GROUP. THE PATIENT, A (B)(6) OLD FEMALE WAS REVISED TO A CEMENTED PRIMARY FEMORAL COMPONENT WITH POLYETHYLENE EXCHANGE IN 2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831357 UNK VANGUARD KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R