BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 16X150MM SPL TPR DIST

    MDR report key: 10080631 · Received May 21, 2020

    Report

    Report Number
    0001825034-2020-02091
    Event Type
    Injury
    Date Received
    May 21, 2020
    Report Date
    September 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). SOURCE: (B)(6). CONCOMITANT MEDICAL DEVICES: CATALOG NUMBER:11-300816 LOT NUMBER: 796550; CATALOG NUMBER:22-301112 LOT NUMBER:013410; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN CUP. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02092, 0001825034-2020-02093, 0001825034-2020-02094, 0001825034-2020-02095. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS BEING INDICATED FOR A REVISION DUE TO UNKNOWN REASONS WITH SUSPECTED INFECTION. HOWEVER, A REVISION HAS NOT BEEN REPORTED. 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
    542262 ARCOS 16X150MM SPL TPR DIST PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 796550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other