BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ F HI 70MM HA

    MDR report key: 7096466 · Received December 7, 2017

    Report

    Report Number
    0001825034-2017-10839
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 10, 2017
    Report Date
    November 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF ACTUAL DEVICE RECEIVED. VISUAL INSPECTION FOUND DEBRIS AFFIXED TO THE POROUS COATING. THE TOP OF THE CONE BODY IS SCRATCHED, LIKELY FROM ATTEMPTS TO ASSEMBLE THE DEVICES. THE CONE IS ATTACHED TO A BIOLOX CERAMIC HEAD. DEVICE HISTORY RECORD (DHR) WAS REVIEWED WITH NO DEVIATIONS. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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 · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 11-300819, ARCOS 19X150MM SPL TPR DIST, 677740. (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WARSAW AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) K090757. CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 10838.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY, IT WAS NOTED THAT THE PROXIMAL STEM DISASSOCIATED FROM THE DISTAL STEM. THE BODY CAME LOOSE FROM THE STEM WHILE THE SCREW WAS WELL FIXED. ANOTHER SET OF STEMS WERE USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873918 ARCOS CON SZ F HI 70MM HA PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 466550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention