BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ B STD 60MM TRL

    MDR report key: 19124850 · Received April 17, 2024

    Report

    Report Number
    0001825034-2024-01040
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    March 25, 2024
    Report Date
    July 12, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304484702
    PMA / PMN Number
    K090757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. H10 . NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WENT TO ATTACH THE TRIAL TO THE STEM AND IT WOULD NOT THREAD ON. THE SCREW SEEMS TO BE DAMAGED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023758 ARCOS CON SZ B STD 60MM TRL INSTRUMENT, HIP KWA ZIMMER BIOMET, INC. N/A 054608 00880304484702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown