BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ A HI 60MM

    MDR report key: 20174152 · Received September 9, 2024

    Report

    Report Number
    0001825034-2024-02174
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 21, 2024
    Report Date
    October 18, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304474085
    PMA / PMN Number
    K090757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 11-300812 ARCOS 12X150MM SPL TPR DIST 073460. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. 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 AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H3, H4, H6, H10. SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SCUFFING TO THE INTERNAL TAPER OF THE BODY ALONG WITH SCUFFING TO THE STEM TAPER. THE DIAMETER OF THE STEM WAS CHECKED PER THE PRINT FOR PRODUCT ID. THE STEM AND BODY TAPERS ARE BOTH CHECKED 100% AT MANUFACTURING. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT CANNOT BE CONFIRMED. 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 DURING A HIP REVISION WITH ARCOS TWO-PIECE SYSTEM. THE SURGEON WENT TO IMPLANT THE CONE BODY ONTO THE TAPERED STEM AND THE CONE BODY WOULD NOT ENGAGE. TRIED ANOTHER CONE BODY THINKING IT WAS A BAD TAPER ON THE BODY AND IT DID THE SAME THING. THE TAPER ON THE REVISION STEM WAS BAD CAUSING AN HOUR DELAY. OPENED A NEW STEM AND IMPLANTED IT WITH NO PROBLEMS WITH THE CONE BODY ENGAGING THIS TIME. THE SURGEON WANTED THESE IMPLANTS NOT CHARGED BECAUSE SURGICAL TECHNIQUE WAS FOLLOWED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510631 ARCOS CON SZ A HI 60MM PROSTHESIS, HIPS KWA ZIMMER BIOMET, INC. N/A 66404136 00880304474085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female