BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR TIBIAL AUGMENTATION BLOCK

    MDR report key: 7142036 · Received December 22, 2017

    Report

    Report Number
    0001825034-2017-11385
    Event Type
    Injury
    Date Received
    December 22, 2017
    Report Date
    April 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    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. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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). MEDICAL PRODUCTS: VANGUARD DCM TIBIAL BEARING CAT#: 183888, LOT#: 205660. BIOMET MODULAR TIBIAL LOCKING BAR CAT#: 141205, LOT#: 516560. 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. 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.

    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
    921162 BIOMET MODULAR TIBIAL AUGMENTATION BLOCK PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 222670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R