BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR FEMORAL

    MDR report key: 7140341 · Received December 21, 2017

    Report

    Report Number
    0001825034-2017-11432
    Event Type
    Injury
    Date Received
    December 21, 2017
    Report Date
    December 21, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 141356, REGENEREX PRIMARY PATELLA 3 PEG, LOT # 713640. CATALOG #: 141273, REGENEREX BIOMET PRIMARY TIBIAL TRAY WITH LOCKING BAR, LOT # 104860. CATALOG #: EP-183540, VANGUARD TIBIAL BEARING CR LIPPED, LOT # 074220. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD 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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07027, AND 11433.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, LOOSENING, AND INSTABILITY APPROXIMATELY THREE YEARS POST-IMPLANT OF TOTAL KNEE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918099 VANGUARD CR FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 495800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other