BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS 18 X 190MM STS STEM TRL

    MDR report key: 9500368 · Received December 20, 2019

    Report

    Report Number
    0001825034-2019-05672
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Report Date
    March 4, 2020
    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
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 31-300818 ARCOS 18 X 150 MM STS STEM TRL LOT#: 843340, CATALOG#: 31-301300 ARCOS CON SZ A STD 50 MM TRL LOT#: 422427, CATALOG#: 31-301302 ARCOS CON SZ B STD 60 MM TRL LOT#: 429960. REPORT SOURCE: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05671, 0001825034-2019-05676, 0001825034-2019-05677.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMAL BODY WOULD NOT DISENGAGE FROM THE 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
    1299737 ARCOS 18 X 190MM STS STEM TRL PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 835540

    Patients

    Seq Age Sex Outcome Treatment
    1