BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINBN VANGUARD INT PS ANAT FM R 75MM

    MDR report key: 22139248 · Received June 4, 2025

    Report

    Report Number
    3002806535-2025-00219
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 16, 2025
    Report Date
    October 20, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    MBH
    UDI-DI
    05019279124527
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024229662. G2 ¿ FOREIGN ¿ POLAND. 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 K122745. 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTION WAS CORRECTED: H6 - COMPONENT CODE. VISUAL EXAMINATION OF THE PROVIDED PICTURES AND RETURNED PRODUCT SHOWED A CARTON WITH A TORN CORNER AND GENERAL WEAR, WHILE THE BOX APPEARED UNDAMAGED. THE BLISTER WAS CRACKED FROM THE LOWER LEFT TO THE UPPER RIGHT CORNER ON ONE SIDE, COMPROMISING STERILITY. A REVIEW OF THE DEVICE MANUFACTURING RECORDS IDENTIFIED TWO NON-CONFORMANCES POTENTIALLY RELATED TO THE REPORTED EVENT. FIRST, NOTED THAT THE OUTER PACKAGING OF THE STERILE PRODUCT INSTRUCTED PLACEMENT OF BLISTER WITH THE TYVEK LID FACING DOWNWARD, WHEREAS IT SHOULD BE PLACED TYVEK LID UP TO ALLOW ADDITIONAL SPACE IN THE BOX. HEALTH HAZARD EVALUATION DETERMINATION WAS RAISED IN RESPONSE TO RELATED COMPLAINTS, THE ROOT CAUSE WAS IDENTIFIED, AND THE BOX SIZE WAS SUBSEQUENTLY INCREASED. SECOND NON-CONFORMANCE INDICATED THAT THE CURRENT PACKAGING CONFIGURATION FOR THE FEMORAL DEVICE CAUSED BLISTER BULGING DURING PACKING; USE OF POUCH WAS IMPLEMENTED TO PREVENT DEFORMATION. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ATTRIBUTED TO THIN AND VARIABLE BLISTER WALL THICKNESS COMBINED WITH INSUFFICIENT HEADSPACE IN THE SHELF CARTON, RESULTING IN BLISTER DEFORMATION. 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

    DURING THE SURGERY IT WAS FOUND THAT THE PLASTIC INTERNAL BOX WITH THE STERILE IMPLANT WAS DAMAGED, CRACKED AND HAD HOLES. THE SURGERY WAS COMPLETED WITH AN ALTERNATIVE IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER 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
    709423 TINBN VANGUARD INT PS ANAT FM R 75MM KNEE PROSTHESIS MBH BIOMET UK LTD. 3819312 05019279124527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown