BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TORNIER PERFORM PERIPHERAL SCREW

    MDR report key: 21573885 · Received March 11, 2025

    Report

    Report Number
    0001649390-2025-00138
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    February 8, 2025
    Report Date
    March 11, 2025
    Manufacturer
    TORNIER INC
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: (B)(6) STUDY: SHOULDER ID. PATIENT PRESENTED TO ED ON (B)(6) 2025 S/P GENERALIZED WEAKNESS (SLID TO FLOOR FROM CHAIR) AND FEVER AND WAS FOUND TO HAVE ACUTE PE [PULMONARY EMBOLISM]. PATIENT HOSPITALIZED AT (B)(6) BEGINNING ON (B)(6) 2025. X-RAY OF R SHOULDER OBTAINED IN ED AND SHOWED INTACT HARDWARE WITHOUT COMPLICATION. ON (B)(6) 2025: HEMATOMA - NARRATIVE: LEFT LOWER QUADRANT (LLQ) ABDOMINAL PAIN SECONDARY TO LARGE ACTIVE RECTUS SHEATH HEMATOMA IN THE SETTING OF NEW ANTICOAGULATION THERAPY. WARFARIN HELD AND REVERSED W/ VITAMIN K. PT REMAINS HOSPITALIZED. ON (B)(6) 2025: ACUTE DEEP VENOUS THROMBOSIS IN LEFT GASTROCNEMIUS VEINS. PT REMAINS HOSPITALIZED. OUTCOME: NOT RECOVERED/NOT RESOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149618 UNKNOWN TORNIER PERFORM PERIPHERAL SCREW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX TORNIER INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention