BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM TIBIA

    MDR report key: 7767612 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07688
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    January 9, 2006
    Report Date
    October 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 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). PRODUCTS: 183210 ¿ VANGUARD COMPLETE KNEE SYSTEM FEMUR - UNKNOWN. 141225 ¿ TIBIAL TRAY ¿ UNKNOWN. UNKNOWN ¿ PATELLA ¿ UNKNOWN. THERAPY DATE: (B)(6) 2006. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 07683; 0001825034 - 2018 - 07694; 0001825034 - 2018 - 07697.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS NOTED TO HAVE RIGHT LOWER EXTREMITY NONOBSTRUCTING CHRONIC THROMBUS SEEN IN THE RIGHT SFV, PROXIMAL, DISTAL, MEDICAL, AND POPLITEAL VEINS APPROXIMATELY 8 MONTHS POST PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608779 VANGUARD COMPLETE KNEE SYSTEM TIBIA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization . | .