BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ A STD 50MM HA 0MM SZ A

    MDR report key: 11384845 · Received February 26, 2021

    Report

    Report Number
    0001825034-2021-00576
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    February 18, 2021
    Report Date
    April 13, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, ITEM#: 22-301300 DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, ITEM#: 22-301300 DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN DAY IN (B)(6) 2014. CONCOMITANT MEDICAL DEVICES: CATALOG#: 22-300814 ARCOS 14X150MM SPL TPR DIST HA X 150MM LOT#: 737850. FOREIGN: (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K090757. 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: 0001825034-2021-00574.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS AND 3 MONTHS POST IMPLANTATION DUE TO FRACTURE OF THE ARCOS STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284625 ARCOS CON SZ A STD 50MM HA 0MM SZ A PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 210390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R