BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCHANGEABLE ULNAR ASSEMBLY

    MDR report key: 9217785 · Received October 22, 2019

    Report

    Report Number
    0001822565-2019-04479
    Event Type
    Injury
    Date Received
    October 22, 2019
    Report Date
    January 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    K181307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE 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

    THE PATIENT IS BEING PLANNED TO REVISE DUE TO HUMERAL COMPONENT LOOSENING AND FRACTURE.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE 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). UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS: 32810502504 INTERCHANGEABLE HUMERAL ASSEMBLY 61405602, CEMENT, BONE SURGIAL SIMPLEX P MLRO76, RESTRICTOR, CEMENT REALITY 10MM K12315. . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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: 0001822565 - 2019 - 04480.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT ELBOW ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS PLANNED TO BE REVISED DUE TO UNKNOWN REASON. NO REVISION HAS BEEN REPORTED TO DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012744 INTERCHANGEABLE ULNAR ASSEMBLY ELBOW PROSTHESIS JDC ZIMMER BIOMET, INC. 61097162

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R