BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCHANGEABLE HUMERAL ASSEMBLY

    MDR report key: 9217777 · Received October 22, 2019

    Report

    Report Number
    0001822565-2019-04480
    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
    Product Problem
    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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. REVIEW OF THE AVAILABLE RADIOGRAPHS IDENTIFIED: RIGHT ELBOW ARTHROPLASTY WITH SIGNIFICANT LOOSENING OF THE HUMERAL COMPONENT AS WELL AS POSSIBLE BONY FRACTURE OF THE DISTAL HUMERUS. LOOSENING IS IDENTIFIED INVOLVING THE HUMERAL COMPONENT WITH ASSOCIATED MALALIGNMENT. NO DISLOCATION. BONY RESECTION OF THE CORONOID PROCESS ALSO SEEN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 32810505302 INTERCHANGEABLE ULNAR ASSEMBLY 61097162; CEMENT, BONE SURGICAL 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: 0001822565-2019-04479.

    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
    1012561 INTERCHANGEABLE HUMERAL ASSEMBLY ELBOW PROSTHESIS JDC ZIMMER BIOMET, INC. 61405602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R