BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER PYROCARBON HUM HEAD DIA 48MMX18MMX1.5MM ECC

    MDR report key: 22530892 · Received July 17, 2025

    Report

    Report Number
    3000931034-2025-00390
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    June 16, 2025
    Report Date
    November 24, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    QKW
    UDI-DI
    03700434019544
    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

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    DEVICE CODE UPDATED. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED. 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. IN THE INDICATIONS FOR USE, IN ANATOMIC CONFIGURATION, THE IFU MENTIONED ,THE TORNIER FLEX SHOULDER SYSTEM IS TO BE USED ONLY IN PATIENTS WITH AN INTACT OR RECONSTRUCTABLE ROTATOR CUFF. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE ROTATOR CUFF TEAR THAT CAUSED THE REVISION IS DUE THE PATIENT¿S FALL, AND THEREFORE IS PATIENT RELATED. AS FOR THE RE-USE OF THE SAME BRAND OF DEVICE AFTER THE ROTATOR CUFF TEAR WAS REPORTED, THE ROOT CAUSE IS DUE TO AN OFF LABEL USE OF THE SURGEON. INDEED, THE IFU MENTIONS THAT THE TORNIER FLEX SHOULDER SYSTEM CAN ONLY BE USED IN PATIENTS WITH A RECONSTRUCTABLE ROTATOR CUFF. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED. 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. IN THE INDICATIONS FOR USE, IN ANATOMIC CONFIGURATION, THE IFU MENTIONED, THE TORNIER FLEX SHOULDER SYSTEM IS TO BE USED ONLY IN PATIENTS WITH AN INTACT OR RECONSTRUCTABLE ROTATOR CUFF. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE EVENT WAS CAUSED BY AN EXPLANTATION OF THE HUMERAL HEAD WHEREAS THE IFU MENTION THAT THE TORNIER FLEX SHOULDER SYSTEM CAN BE USED IN PATIENTS WITH A RECONSTRUCTABLE ROTATOR CUFF. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    PT FELL OVER AND TORE SUBSCAPULARIS. SURGEON WASN¿T SURE IF HE NEEDED TO REPLACE THE HEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE PT FELL OVER AND TORE SUBSCAPULARIS. SURGEON WASN¿T SURE IF HE NEEDED TO REPLACE THE HEAD. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE PT FELL OVER AND TORE SUBSCAPULARIS. SURGEON WASN'T SURE IF HE NEEDED TO REPLACE THE HEAD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913949 TORNIER PYROCARBON HUM HEAD DIA 48MMX18MMX1.5MM ECC SHOULDER JOINT HUMERAL CERAMIC HEAD QKW TORNIER S.A.S. 8202BA 03700434019544

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention