BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD 360 DISTAL AUGMENT

    MDR report key: 6921751 · Received October 6, 2017

    Report

    Report Number
    0001825034-2017-08024
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    August 23, 2017
    Report Date
    November 21, 2017
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS IT WAS CONFIRMED THERE WAS NO ADVERSE EVENT. RECORD CREATED IN ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF BIRTH: PATIENT WAS BORN IN 1945. CONCOMITANT MEDICAL PRODUCTS: VANGUARD SSK 360 FEMORAL, CAT#: 185265, LOT#: 2896113; BIOMET SMOOTH KNEE STEM, CAT#: 145024, LOT#: 217700; BIOMET 360 OFFSET ADAPTER, CAT#: 185211, LOT#: 550490; BIOMET SMOOTH KNEE STEM, CAT#: 145022, LOT#: 177410; VANGUARD 360 TIBIAL TRAY, CAT#: 161430, LOT#: 2752284; VANGUARD 360 TIBIAL BEARING, CAT#: 161453, LOT#: 2684679. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE 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: 3002806535-2017-00929, 0001825034-2017-08022, 0001825034-2017-08023, 0001825034-2017-08026, 3002806535-2017-00930, 3002806535-2017-00931. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702300 VANGUARD 360 DISTAL AUGMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 344750

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R