BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP E1 ANTIOXIDANT INFUSED RIGHT LATERAL TIBIAL BEARING 9MM

    MDR report key: 8625655 · Received May 20, 2019

    Report

    Report Number
    0001825034-2019-02258
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    April 16, 2015
    Report Date
    November 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND MEDICAL RECORDS AND THE REPORTED EVENT WAS CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD XP INTERLOK FEMORAL COMPONENT WITH PEGS 62.5MM RIGHT CATALOG #: 195204 LOT #: 589220, VANGUARD XP INTERLOK TIBIAL TRAY 63MM CATALOG #: 195751 LOT #: 801960, VANGUARD XP E1 ANTIOXIDANT INFUSED RIGHT MEDIAL TIBIAL BEARING 9MM CATALOG #: 195842 LOT #: 695970. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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 PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2019-02256, 0001825034-2019-02257, 0001825034-2019-02258, 0001825034-2019-02259. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, SWELLING, DIFFICULTY AMBULATING, LIMITED RANGE OF MOTION AND DIFFICULTY PERFORMING DAILY ACTIVITIES WITHIN THE TWO (2) YEARS FOLLOWING RIGHT KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417212 VANGUARD XP E1 ANTIOXIDANT INFUSED RIGHT LATERAL TIBIAL BEARING 9MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 968790

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention