BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGARD XP FEMORAL COMPONENT WITH PEGS LEFT 57.5MM

    MDR report key: 18464370 · Received January 8, 2024

    Report

    Report Number
    0001825034-2024-00024
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    October 11, 2023
    Report Date
    June 4, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00880304560437
    PMA / PMN Number
    K132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - VANGUARD XP-AS E1 LEFT MEDIAL/RIGHT LATERAL TIBIAL BEARING 10MM X 65/67MM CATALOG #: 195543 LOT #: 255250, VANGUARD XP-XP E1 LEFT LATERAL BEARING 10MM X 63/65/67MM CATALOG #: 195808 LOT #: 103500, VANGUARD XP CRUCIATE RETAINING TIBIAL TRAY 65MM CATALOG #: 195270 LOT #: 342320 G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN JAPAN 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: 0001825034-2024-00022 0001825034-2024-00023

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - FEMUR. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PATELLAR AND TIBIAL BEARING DISLOCATION AND PAIN APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. THE PATIENT'S PATELLA WAS RESURFACED AND THE TIBIAL BEARINGS WERE REPLACED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950022 VANGARD XP FEMORAL COMPONENT WITH PEGS LEFT 57.5MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 272320 00880304560437

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Hospitalization| R SEE H10 NARRATIVE