BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ E HI 60MM

    MDR report key: 9954782 · Received April 13, 2020

    Report

    Report Number
    0001822565-2020-01355
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Report Date
    August 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304480551
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 0001825034 - 2020 - 03207.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). UDI : (B)(4). 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.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED WITH PACKAGING DAMAGE AND THE STERILITY BARRIER POTENTIALLY COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417462 ARCOS CON SZ E HI 60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 714460 00880304480551

    Patients

    Seq Age Sex Outcome Treatment
    1