BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN TIBIAL TRAY

    MDR report key: 6644870 · Received June 15, 2017

    Report

    Report Number
    0001822565-2017-04036
    Event Type
    Injury
    Date Received
    June 15, 2017
    Report Date
    June 14, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: UNKNOWN FEMORAL CATALOG #: UNKNOWN LOT #: UNKNOWN, UNKNOWN BEARING CATALOG #: UNKNOWN LOT #: UNKNOWN. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MCSHANE, MICHAEL (2014) SEMINARS IN ARTHROPLASTY 25 (2014) 172-178 HTTP://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S1045452714000996. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT EXPERIENCED ASEPTIC TIBIAL COMPONENT FAILED AT TWO YEARS POSTOPERATIVE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424848 UNKNOWN NEXGEN TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability