BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER PYROCARBON HUM HEAD DIA 48MMX18MMX4.0MM ECC

    MDR report key: 20268054 · Received September 20, 2024

    Report

    Report Number
    3000931034-2024-00573
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    August 24, 2024
    Report Date
    December 18, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    QKW
    PMA / PMN Number
    DEN220012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. PHOTOS OF THE EXPLANTED DEVICE ARE NOT SUFFICIENT TO CARRY OUT PRODUCT INSPECTIONS. NO DEFECT WAS NOTICED ON THE PYROCARBON SURFACE OR ON THE METALLIC COMPONENT. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION OF PYROCARBON HEMIARTHROPLASTY WAS NEEDED TO REVERSE THE TOTAL SHOULDER ARTHROPLASTY DUE TO ROTATOR CUFF FAILURE. NO PROSTHESIS FAULT. THE IMPLANTED STEM WAS LEFT IN SITU AND CONVERTED TO A REVERSE TRAY/ LINER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION OF PYROCARBON HEMIARTHROPLASTY WAS NEEDED TO REVERSE THE TOTAL SHOULDER ARTHROPLASTY DUE TO ROTATOR CUFF FAILURE. NO PROSTHESIS FAULT. THE IMPLANTED STEM WAS LEFT IN SITU AND CONVERTED TO A REVERSE TRAY/ LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668168 TORNIER PYROCARBON HUM HEAD DIA 48MMX18MMX4.0MM ECC SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEMENTED OR UN QKW TORNIER S.A.S. 3503AU

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown Required Intervention