BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B STD 70MM

    MDR report key: 10586370 · Received September 25, 2020

    Report

    Report Number
    0001825034-2020-02149
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    March 10, 2020
    Report Date
    September 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    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). UDI#: (B)(4). IMPLANT DATE - (B)(6) 2019. CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 11-300815 ARCOS 15X150MM SPL TPR DIST LOT#: 137490, CATALOG#: 650-1161 DELTA CER FEM HD 32/+3MM T1 LOT#: 2016110787, FOREIGN: (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02150.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 YEAR POST IMPLANTATION DUE TO PAIN AND STEM SUBSIDENCE. THE CONE BODY, DISTAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053327 ARCOS CON SZ B STD 70MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 629570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R