BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP-XP TIBIAL TRAY

    MDR report key: 7861297 · Received September 10, 2018

    Report

    Report Number
    0001825034-2018-08740
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    August 14, 2018
    Report Date
    March 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI #: (B)(4). THE LOCKING BAR IS PACKAGED WITH THE TIBIAL TRAY (CATALOG 195756 LOT 625610); THE LOCKING BAR WAS REMOVED BUT THE TIBIAL TRAY REMAINS IMPLANTED. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS BEEN COMPLETED. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS WEAR. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCKING BAR IS PACKAGED WITH THE TIBIAL TRAY (CATALOG 195756 LOT 625610); THE LOCKING BAR WAS REMOVED BUT THE TIBIAL TRAY REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCT: VGXPINTLK F L XP67.5, CATALOG # 195923, LOT # 378260; VGXPXP E1 B LM 9X71, CATALOG # 195884, LOT # 115970; VGXPXP E1 B LL 9X71, CATALOG # 195814, LOT # 132620; A PAT STD 3PEG34X8.5, CATALOG # 184766, LOT # 083530. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED TO ADDRESS THE LOCKING BAR BACKING OUT FROM THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703498 VANGUARD XP-XP TIBIAL TRAY KNEE PROSTHESIS MBH ZIMMER BIOMET, INC. N/A 625610

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R