BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER PYROCARBON HUM HEAD DIA 50MMX16MMX4.0MM ECC

    MDR report key: 24428725 · Received February 24, 2026

    Report

    Report Number
    3000931034-2026-00219
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    November 20, 2024
    Report Date
    April 14, 2026
    Manufacturer
    TORNIER S.A.S.
    Product Code
    QKW
    UDI-DI
    03700434020267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S. BUT A SIMILAR DEVICE (DWH151) IS COMMERCIALLY AVAILABLE IN THE U.S UNDER PMA/510(K) : DEN220012 THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE NATIONAL JOINT REGISTRY. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY. PLEASE NOTE, THAT REPORTS RECEIVED FROM THE NATIONAL JOINT REGISTRY ARE NOT PUBLISHED REPORTS AND THEREFORE WEB LINK IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE HEMI SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED IN 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO NATIVE GLENOID SURFACE EROSION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250510 TORNIER PYROCARBON HUM HEAD DIA 50MMX16MMX4.0MM ECC SHOULDER JOINT HUMERAL CERAMIC HEAD/ METALLIC STEM QKW TORNIER S.A.S. 3628AV 03700434020267

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention