BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD MONO FINNED STM TIB 71X14

    MDR report key: 20877226 · Received December 9, 2024

    Report

    Report Number
    3002806535-2024-00453
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 13, 2024
    Report Date
    May 21, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    UDI-DI
    00887868354380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. 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 K113369. PRODUCT WAS RETURNED AND VISUALLY ASSESSED. NO OUTER PACKAGING CARTON OR LABELS WERE RETURNED. THE OUTER CAVITY EXHIBITS DAMAGE (PUNCTURED/FRACTURED) AND HAS CRACKED AROUND THE TOP OF THE CAVITY. THE TYVEK SEAL HAD BEEN PEELED BACK SO OPENING THE OUTER BARRIER. THE IMPLANT WAS STILL PACKAGED WITHIN THE INNER POUCH, AND IT APPEARS THAT REMAINS INTACT. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. RETURN OF THE OUTER BOX MIGHT HAVE ENABLED THE CONCLUSION OF DAMAGE DURING TRANSPORTATION AND FURTHERMORE, IT WAS NOT REPORTED THAT THE OUTER PACKAGING WAS ALSO DAMAGED TO SUPPORT THAT. 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.

    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 IT WAS DISCOVERED DURING THE SURGERY THAT THE PACKAGING OF THE IMPLANT WAS DAMAGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337504 VANGUARD MONO FINNED STM TIB 71X14 KNEE PROSTHESIS JWH BIOMET UK LTD. N/A 7026956 00887868354380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown