BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SERIES A PAT STD 37 3 PEG

    MDR report key: 23294136 · Received October 15, 2025

    Report

    Report Number
    0001825034-2025-03227
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 15, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K040770
    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: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; THE REPORTED EVENT COULD NOT BE CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4) D10: 183050 VANGUARD CR POR FEM-RT 67.5 LOT# 673260, 189040 VANGUARD ANT STBLZD BRG 10X67 LOT# 852330, 3325-040, GENTAMICIN BONE CEMENT, 8134377.. G2: AUSTRALIA CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TKA ON AN UNKNOWN DATE. SUBSEQUENTLY, THEY WERE REVISED DUE TO PAIN AND STIFFNESS. ALL FORMER IMPLANTS WERE REPLACED. TO ADDRESS THE OVERALL TIGHTNESS IN BOTH FLEXION AND EXTENSION, THE SURGEON DOWNSIZED THE FEMORAL COMPONENT, RESECTED MORE BONE OFF THE FEMUR AND TIBIA AND DEBRIDEMENT SIGNIFICANT AMOUNTS OF SCAR TISSUE. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237221 VANGUARD SERIES A PAT STD 37 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 450300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11