BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD MONO FINNED STM TIB 71X8

    MDR report key: 17486218 · Received August 9, 2023

    Report

    Report Number
    3002806535-2023-00269
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 10, 2023
    Report Date
    May 19, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    UDI-DI
    00887868354359
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THAT THE PHOTOGRAPH DOES NOT CLEARLY INDICATE THE ALLEGED DAMAGE TO THE BEARING SURFACE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. REPORTED EVENT DID OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE, BUT REVIEW OF THE MEDICAL RECORDS HAS NOT BEEN PERFORMED, AS THE EVENT IS NOT RELATED TO THE MEDICAL PROCEDURE. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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). G2 - FOREIGN : UNITED KINGDOM. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H1, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: G1-2, H4. D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K172524. PRODUCT WAS RETURNED AND VISUALLY ASSESSED WHICH CONFIRMED THE COMPLAINT. THE BEARING SURFACE HAS SCRATCHES AND DENTS AND GOUGES. NO PACKAGING WAS RETURNED THEREFORE NO FURTHER ASSESSMENT AS TO THE CAUSE OF THE DAMAGE COULD BE MADE. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON NOTICED SOME SCRATCH DAMAGE ON THE BEARING SURFACE OF THE TIBIAL COMPONENT, BEFORE IMPLANTATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    1892978 VANGUARD MONO FINNED STM TIB 71X8 KNEE PROSTHESIS JWH BIOMET UK LTD. 7440146 00887868354359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown