BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VG 360 5N1 LK TIB TRL 79/83X10

    MDR report key: 11945920 · Received June 7, 2021

    Report

    Report Number
    0001825034-2021-01713
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 4, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBV
    UDI-DI
    00880304515994
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES PROVIDED. VISUAL EVALUATION OF THE DEVICE PICTURES SHOWS SIGNS OF REPEATED USE AND A PIECE HAS FRACTURED OFF. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FRACTURED DURING TRIALING. THE KNEE WAS VERY TIGHT AND THE DEVICE FRACTURED WHILE THE SURGEON WAS TRYING TO REMOVE IT FROM THE PATIENT. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848069 VG 360 5N1 LK TIB TRL 79/83X10 PROSTHESIS KNEE MBV ZIMMER BIOMET, INC. N/A 352630 00880304515994

    Patients

    Seq Age Sex Outcome Treatment
    1