BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT 360 TIB TRAY 71MM

    MDR report key: 8278129 · Received January 25, 2019

    Report

    Report Number
    0001825034-2019-00301
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    December 20, 2018
    Report Date
    October 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS VISUAL INSPECTION SHOWS ALL THE PIECES TO STILL BE ASSEMBLED TO EACH OTHER AND THE REASON FOR THE REVISION IS UNKNOWN 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 185650, BMT 360 TIB SM CRUCIATE WING, LOT # 538320, CATALOG #: 185211, BMT 360 TIB 5.0 OFFSET ADAPTER, # 405610, CATALOG #: 141614, BMT SPLINED KNEE STM 80X14MM, LOT # 670470, CATALOG #: 183642, VNGD PS TIB BRG 12X71/75MM, LOT # 653710. (B)(6). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SECOND REVISION OF THEIR TIBIA DUE TO AN UNKNOWN KNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70104 BMT 360 TIB TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 241010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R