BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINBN VANGUARD INT PS ANAT FM R 65MM

    MDR report key: 21547059 · Received March 7, 2025

    Report

    Report Number
    3002806535-2025-00108
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    April 24, 2024
    Report Date
    March 7, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    UDI-DI
    00887868355554
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4 - THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 - FOREIGN: JAPAN 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 K113550. ONE BOX WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE OUTER BOX HAS BEEN DAMAGED BREAKING THE PLASTIC WRAP AND EXPOSING THE CAVITY. THE BLISTER CAVITY HAS BEEN DAMAGED AND CREASED BREAKING THE PLASTIC BARRIER OF THE CAVITY. THE PAPER TYVEK IS STILL IN PLACE. THE STERILE BARRIER HAS BEEN BROKEN. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED ISSUE IS LIKELY ATTRIBUTED TO DAMAGE RECEIVED DURING TRANSIT / STORAGE. 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 DURING AN INSPECTION, IT WAS IDENTIFIED THAT BOTH THE OUTER PACKAGING AND THE INNER STERILE BARRIER OF THE IMPLANT WERE COMPROMISED. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535164 TINBN VANGUARD INT PS ANAT FM R 65MM KNEE PROSTHESIS JWH BIOMET UK LTD. 7685373 00887868355554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown