BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD 360 FEMORAL

    MDR report key: 6866713 · Received September 14, 2017

    Report

    Report Number
    0001825034-2017-07113
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    August 23, 2017
    Report Date
    January 6, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET SMOOTH STEM, CAT#: 145026 LOT#: 045450. VANGUARD 360 TIBIAL TRAY, CAT#: 161432 LOT#: 2857200. BIOMET SMOOTH STEM, CAT#: 145022 LOT#: 470020. UNKNOWN VANGUARD BEARING. UNKNOWN PALACOS CEMENT. REPORT SOURCE: (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: 0001825034-2017-07113, 0001825034-2017-07114, 0001825034-2017-07115, 0001825034-2017-07116, 0001825034-2017-07117. PRODUCT LOCATION UNKNOWN.

    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. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. IT WAS NOTED THAT A RIGHT FEMORAL COMPONENT WAS IMPLANTED INTO PATIENT'S LEFT KNEE. HENCE THE ROOT CAUSE OF THE REPORTED ISSUE IS DETERMINED TO BE USER ERROR. 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 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
    644019 VANGUARD 360 FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 3702874

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R