BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM

    MDR report key: 22642267 · Received July 29, 2025

    Report

    Report Number
    0001825034-2025-02297
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    July 7, 2025
    Report Date
    October 14, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304271937
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, A2, A3, B4, B5, D1, D4, D6A, D10, G3, G4, G6, H2, H4, H6, H11. D10 - CONCOMITANT DEVICES - BIOMET POLISHED FINNED TIBIAL TRAY 71MM CATALOG #: 141253 LOT #: 2016090409, BIOMET SERIES A 3 PEG THIN PATELLA 37MM X 8.6MM CATALOG #: 184788 LOT #: 160430, VANGUARD POSTERIOR STABILIZED INTERLOK FEMORAL COMPONENT LEFT 62.5MM CATALOG #: 183126 LOT #: 924160

    Additional Manufacturer Narrative · 0

    (B)(4) D10 - CONCOMITANT DEVICES - UNKNOWN VANGUARD FEMORAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN BIOMET TIBIAL COMPONENT CATALOG #: NI LOT #: NI. G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN AUSTRALIA. THE COMPLAINANT HAS NOT YET INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H11. THE REPORTED EVENT COULD NOT BE CONFIRMED AS MEDICAL RECORDS WERE NOT PROVIDED. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED AS THE EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED DEVICE. STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. THE DEVICE WAS VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESSES FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS THAT MAY INCLUDE HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER-RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. THE ROOT CAUSE WAS DETERMINED TO BE TRACED TO NON-DEVICE RELATED FACTORS. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION OF THE TIBIAL BEARING DUE TO INFECTION APPROXIMATELY EIGHT (8) YEARS FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE TIBIAL BEARING TO ADDRESS UNKNOWN COMPLICATIONS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788731 VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 749170 00880304271937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.