BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS 3.5MM HEX DRIVE

    MDR report key: 17886145 · Received October 6, 2023

    Report

    Report Number
    0001825034-2023-02315
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 23, 2023
    Report Date
    January 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304484498
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: B4, G3, G6, H2, H6, H10. CORRECTION: H4. ONE ARCOS 3.5MM HEX DRIVE WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE LINER WAS EMBEDDED IN THE SHELL AND COULD NOT BE REMOVED. THERE WAS NO VISIBLE DAMAGE TO THE LINER. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 31-301303. ITEM NAME: ARCOS CON SZ C STD 60MM TRL. LOT #: 053430. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET. THE INVESTIGATION IS CURRENTLY IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRIVER FRACTURED. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341725 ARCOS 3.5MM HEX DRIVE PROSTHETIC, HIP KWA ZIMMER BIOMET, INC. N/A ZB180201 00880304484498

    Patients

    Seq Age Sex Outcome Treatment
    1 Male PLEASE SEE H10