BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR TIBIAL LOCKING BAR

    MDR report key: 7142015 · Received December 22, 2017

    Report

    Report Number
    0001825034-2017-11376
    Event Type
    Injury
    Date Received
    December 22, 2017
    Report Date
    April 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK063732
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: VANGUARD DCM TIBIAL BEARING CAT#: 183888, LOT#: 205660; BIOMET OFFSET TIBIAL TRAY CAT#: 141483, LOT#: 482440; VANGUARD SSK FEMORAL COMPONENT CAT#: 183304, LOT#: 220670; BIOMET SPLINED KNEE STEM V2 CAT#: 148321, LOT#: 661140; BIOMET SPLINED KNEE STEM V2 CAT#: 148308, LOT#: 978960; VANGUARD SERIES-A STANDARD PATELLA CAT#: 184764, LOT#: 986750; BIOMET OFFSET TIBIAL TRAY ADAPTOR CAT#: 141491, LOT#: 221940; VANGUARD FEMORAL DISTAL AUGMENT CAT#: 184204, LOT#: 747090; VANGUARD FEMORAL-RL/LM DISTAL AUGMENT CAT#: 184184, LOT#: 046490; BIOMET MODULAR TIBIAL AUGMENTATION BLOCK CAT#: 141763, LOT#: 222670; BIOMET MODULAR TIBIAL AUGMENTATION BLOCK CAT#: 141763, LOT#: 222670. THE PRODUCT HAS NOT BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 11375, 0001825034 - 2017 - 11376, 0001825034 - 2017 - 11377, 0001825034 - 2017 - 11378, 0001825034 - 2017 - 11379, 0001825034 - 2017 - 11380, 0001825034 - 2017 - 11381, 0001825034 - 2017 - 11382, 0001825034 - 2017 - 11383, 0001825034 - 2017 - 11384, 0001825034 - 2017 - 11385, 0001825034 - 2017 - 11386 . PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TWO MONTHS AFTER KNEE PROCEDURE DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920945 BIOMET MODULAR TIBIAL LOCKING BAR PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 516560

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R