BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD TIBIAL BEARING ANTERIOR STABILIZED (AS) 67 MM WIDTH 10 MM THICKNESS

    MDR report key: 23548838 · Received November 13, 2025

    Report

    Report Number
    0001822565-2025-04122
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    April 29, 2024
    Report Date
    March 5, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024564428
    PMA / PMN Number
    K183583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: H4. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND MEDICAL RECORDS CONFIRMED THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: SERIES A PAT W/WR STD 28 1 PEG: CATALOG#184702, LOT#65783328; BIOMET CC CRUCIATE TRAY 67MM: CATALOG#141232, LOT#J7510816; VANGUARD CR POR FEM-RT 65: CATALOG#183048, LOT#900670 THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. FOLLOWING THE PROCEDURE, THE PATIENT CONTINUED HAVING PAIN AND NEUROPATHY IN THE LEG WITH LIMITED RANGE OF MOTION. DIAGNOSTICS REVEALED DAMAGE TO THE PERONEAL NERVE RESULTING IN FOOT DROP AND DIFFICULTY AMBULATING. PHYSICAL EXAM REVEALED A PALPABLE BAKER¿S CYST, AND X-RAYS SHOWED EXCESSIVE TIBIAL SLOPE. SUBSEQUENTLY, APPROXIMATELY FOUR (4) MONTHS POST-IMPLANTATION, A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ANKYLOSIS AND ARTHROFIBROSIS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983724 VANGUARD TIBIAL BEARING ANTERIOR STABILIZED (AS) 67 MM WIDTH 10 MM THICKNESS PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 65268828 00889024564428

    Patients

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