BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ELBOW

    MDR report key: 10102680 · Received May 29, 2020

    Report

    Report Number
    0001822565-2020-01910
    Event Type
    Injury
    Date Received
    May 29, 2020
    Report Date
    June 8, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

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

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE REPORTED EVENT WAS IDENTIFIED DURING REVIEW OF A JOURNAL ARTICLE. MAHDI SIALA MD, PIERRE LAUMONERIE MD, ABDELLAH HEDJOUDJE MD, STEPHANIE DELCLAUX MD, NICOLAS BONNEVIALLE MD, PHD, PIERRE MANSAT, MD, PHD. OUTCOMES OF SEMICONSTRAINED TOTAL ELBOW ARTHROPLASTY PERFORMED FOR ARTHRITIS IN PATIENTS UNDER 55 YEARS OLD. JOURNAL OF SHOULDER AND ELBOW SURGERY.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RETRIEVED FROM JOURNAL OF SHOULDER AND ELBOW SURGERY (2019) THAT REPORTED A RETROSPECTIVE, SINGLE-CENTER STUDY FROM FRANCE FROM 1998 TO 2008 THAT LOOKED AT OUTCOMES OF SEMI CONSTRAINED TOTAL ELBOW ARTHROPLASTY (TEA) FOR PATIENTS WITH ARTHRITIS UNDER 55 YEARS OLD. THE STUDY REPORTED THE PATIENT TO UNDERGO AN ELBOW RESECTION DUE TO PERIPROSTHETIC INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563829 UNK ELBOW ELBOW PROSTHESIS KWI ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention