BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ B HI 60MM TRL

    MDR report key: 18226180 · Received November 29, 2023

    Report

    Report Number
    0001825034-2023-02779
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 6, 2023
    Report Date
    April 9, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 02774 0001825034 - 2023 - 02775 0001825034 - 2023 - 02776 0001825034 - 2023 - 02777 0001825034 - 2023 - 02778 0001825034 - 2023 - 02780 THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS REQUIRED TO BE AVAILABLE FOR SURGERY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. DEVICE WAS RETURNED AND EVALUATED. DEVICE SHOWS SCUFFING AND WEAR. THE SCREW COULD NOT BE REMOVED FOR FURTHER EVALUATION AND NO GAUGE CHECK WAS DONE AS THE SCREW HAS BEEN USED. 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. THE EVENT WAS CONFIRMED ON ONE UNIT BUT NOT ON THE OTHER SIX. 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 · 0

    IT WAS REPORTED BY THE SURGEON THAT THE TRIALS ARE NOT PROPERLY LOCKING ONTO THE STEM ANYMORE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78315 ARCOS CON SZ B HI 60MM TRL INSTRUMENT, HIP KWA ZIMMER BIOMET, INC. N/A 400816

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female