BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS 16X190MM SPL TPR DIST M

    MDR report key: 12569232 · Received October 4, 2021

    Report

    Report Number
    0001825034-2021-02805
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 23, 2021
    Report Date
    February 11, 2022
    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
    NL
    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, B5, D4, D9, G3, H2, H3, H4, H6 COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ARCOS 16X190MM SPL TPR DIST M AND ARCOS CON SZ A HI 80MM WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE PARTS COULD NOT BE SEPARATED AS THE SET SCREW HEX HAD BEEN ROUNDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CAT# 11-301351 ARCOS CON SZ A HI 80MM LOT# 191890 (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 02806.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ARCOS STEM WAS PLACED IN THE FEMUR AND THE BODY WAS PLACED AFTER THE STEM WAS PUT IN. CORRECT DEPTH HAD BEEN REACHED, HOWEVER THE LOCKING SCREW DID NOT GRIP. AFTER REMOVING THE ENTIRE COMBINATION, THE LOCKING SCREW COULD NO LONGER BE REMOVED. A NEW STEM AND BODY WERE PLACED WITHOUT FURTHER PROBLEMS. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470268 ARCOS 16X190MM SPL TPR DIST M PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 618250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown