BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DISTAL FEMORAL AUGMENT

    MDR report key: 7605656 · Received June 15, 2018

    Report

    Report Number
    0001825034-2018-04057
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    May 7, 2018
    Report Date
    October 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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) MEDICAL PRODUCT: BIOMET 360 TIBIAL AUGMENT, CATALOG #: 185225, LOT #: 243030 BIOMET 360 TIBIAL TRAY, CATALOG #: 185205, LOT #: 747220 BIOMET 360 CRUCIATE WING, CATALOG #: 185650, LOT #: 419530 VANGUARD DISTAL FEMORAL AUGMENT, CATALOG #: 185306, LOT #: 589850 VANGUARD SSK 360 FEMORAL COMPONENT, CATALOG #: 185266, LOT #: 6069511 BIOMET SPLINED KNEE STEM, CATALOG #: 148310, LOT #: 113800 BIOMET SPLINED KNEE STEM, CATALOG #: 148312, LOT #: 029070 SERIES-A STANDARD PATELLA, CATALOG #: 184764, LOT #: 489140 BIOMET TIBIAL LOCKING BAR, CATALOG #: 141205, LOT #: 516600 VANGUARD SSK TIBIAL BEARING, CATALOG #: 183906, LOT #: 473720. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-04054, 0001825034-2018-04055, 0001825034-2018-04056 0001825034-2018-04057, 0001825034-2018-04058, 0001825034-2018-04059, 0001825034-2018-04060, 0001825034-2018-04061, 0001825034-2018-04062, 0001825034-2018-04063, 0001825034-2018-04064. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN. IT WAS ALSO NOTED THAT THE PATIENT HAD A NERVE BURN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449317 VANGUARD DISTAL FEMORAL AUGMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 127510

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention