BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD FEMORAL COMPONENT

    MDR report key: 7798821 · Received August 20, 2018

    Report

    Report Number
    0001825034-2018-08283
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    October 26, 2017
    Report Date
    September 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08281-1; 0001825034-2018-08282-1; 0001825034-2018-08283-1.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS AND ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 08281, 0001825034 - 2018 - 08282, 0001825034 - 2018 - 08283. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A PROLONGED HOSPITALIZATION STAY DUE TO A FIB. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639806 VANGUARD FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization