BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PYROCARBON IMPLANT

    MDR report key: 23642304 · Received November 25, 2025

    Report

    Report Number
    3000931034-2025-00615
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    July 31, 2019
    Report Date
    November 25, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    QKW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. 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.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED IIS NAMED "5-YEAR RADIOGRAPHIC AND CLINICAL OUTCOMES OF PYROCARBON HEMIARTHROPLASTY FOR GLENOHUMERAL ARTHRITIS AND AVASCULAR NECROSIS" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PYROCARBON. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED TILL (B)(6) 2019. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: ONE PATIENT DEMONSTRATED SEVERE MEDIALIZATION AT 2 YEARS, INCREASING TO THREE PATIENTS AT FINAL FOLLOW-UP, WITH A MEDIAN MEDIALIZATION OF 10.2MM. THIS IS CASE 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2851933 UNKNOWN PYROCARBON IMPLANT SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEMENTED QKW TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other