BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAN PS OPEN INTL FEM-RT 62.5

    MDR report key: 15627063 · Received October 18, 2022

    Report

    Report Number
    0001825034-2022-02363
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 28, 2022
    Report Date
    February 22, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00880304270787
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN - ITALY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT (ANNEX G) CODE IS MECHANICAL (G04) - FEMUR. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED FOUND PART#183126 WAS FOUND IN THE PACKAGE OF PART#183106. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING ISSUE. ACTIONS WERE INITIATED TO FURTHER INVESTIGATE THIS ISSUE. 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 A RIGHT KNEE SURGERY, THE COMPONENTS WERE OPENED TO BE IMPLANTED. WHEN THE FEMORAL COMPONENT WAS OPENED, IT WAS NOTED THE BOX CONTAINED A LEFT FEMORAL KNEE COMPONENT. THIS RESULTED IN A 30 MINUTE SURGICAL DELAY. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    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
    2265402 VAN PS OPEN INTL FEM-RT 62.5 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A J7175232 00880304270787

    Patients

    Seq Age Sex Outcome Treatment
    1 Female