BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ULNAR STEM

    MDR report key: 7292044 · Received February 23, 2018

    Report

    Report Number
    0001822565-2018-00997
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    September 20, 2017
    Report Date
    February 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, LITERATURE: BARCO, R. ET AL (2017). TOTAL ELBOW ARTHROPLASTY FOR DISTAL HUMERAL FRACTURES: A TEN-YEAR-MINIMUM FOLLOW-UP STUDY. THE JOURNAL OF BONE AND JOINT SURGERY, 99(18), 1524-1531. DOI: 10.2106/JBJS.16.01222. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT WAS SUCCESSFULLY REVISED DUE TO A POROUS-COATED ULNAR COMPONENT FRACTURE 11 MONTHS POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135192 UNKNOWN ULNAR STEM ELBOW, PROSTHESIS KWI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R