BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD TIBIAL TRAY

    MDR report key: 6910485 · Received October 3, 2017

    Report

    Report Number
    0001825034-2017-07329
    Event Type
    Injury
    Date Received
    October 3, 2017
    Report Date
    April 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: (B)(6) 2017. CONCOMITANT MEDICAL PRODUCTS: VANGUARD POSTERIOR STABILIZED FEMORAL, CAT#: 184514, LOT#: UNKNOWN. REGENEREX 3-PEG PATELLA, CAT#: 141355, LOT#: UNKNOWN. VANGUARD POSTERIOR STABILIZED TIBIAL BEARING, CAT#: 183660, LOT#: UNKNOWN. (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED UNDER BIOMET (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS SUFFERING FROM PAIN IN TIBIA, EIGHT MONTHS AFTER INITIAL IMPLANTATION OF PRODUCTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691352 UNKNOWN VANGUARD TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention