BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORM HUMERAL STEM SZ 4

    MDR report key: 21572491 · Received March 11, 2025

    Report

    Report Number
    0001649390-2025-00129
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    February 8, 2025
    Report Date
    March 11, 2025
    Manufacturer
    TORNIER INC
    Product Code
    PAO
    UDI-DI
    00846832085514
    PMA / PMN Number
    K201315
    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 (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 (B)(6) 2025. X-RAY OF R SHOULDER OBTAINED IN ED AND SHOWED INTACT HARDWARE WITHOUT COMPLICATION. (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. (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
    336430 PERFORM HUMERAL STEM SZ 4 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED PAO TORNIER INC UNKNOWN 00846832085514

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention