BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD ANT STAB TRL 11X71

    MDR report key: 22926021 · Received August 29, 2025

    Report

    Report Number
    0001825034-2025-02738
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    July 31, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304676732
    PMA / PMN Number
    K113550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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; B5; D2; D4; G1; G3; G6; H1; H2; H3; H4; H6 . COMPLAINT CAN BE CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF REPEATED USE IN THE FORM OF GOUGES AND A RAIL ON THE DISTAL SIDE OF THE DEVICE WAS FOUND TO BE FRACTURED OFF. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. 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 THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNDERSIDE OF THE BEARING TRIAL CRACKED OFF IN CS WHILE IT WAS BEING CLEANED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    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
    2222755 VANGUARD ANT STAB TRL 11X71 INSTRUMENT, KNWW JWH ZIMMER BIOMET, INC. N/A 092490 00880304676732

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown