BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD KNEE SYSTEM PS TIBIAL BEARING E1 ANTIOXIDANT INFUSED

    MDR report key: 8626906 · Received May 21, 2019

    Report

    Report Number
    0001822565-2019-02082
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    April 10, 2019
    Report Date
    January 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD PS TIB BRG; P/N: EP-183660, L/N: 388330, BIOMET ILOK PRI TIB TRAY; P/N: 141215, L/N: 782270, BIOMET FINNED PRI STEM; P/N: 141320, L/N: 200840, VAN PS OPEN INTL FEM-RT; P/N: 183110, L/N: J6285154, SERIES A PAT; P/N: 184766, L/N: 594030, BIOMET BC R; P/N: 110035368, L/N: 745DAI1807, BIOMET BC R; P/N: 110035368, L/N: 745DAI1807. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT: (B)(6) 2018. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO POPPING, PAIN AND SCRUNCHING NOISE APPROXIMATELY 1 YEAR POST-IMPLANTATION. SUBSEQUENTLY, THE BEARING WAS REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421981 VANGUARD KNEE SYSTEM PS TIBIAL BEARING E1 ANTIOXIDANT INFUSED PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 388330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R