BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORM NUCLEUS FC SIZE 2 - ANATOMIC

    MDR report key: 24817179 · Received April 8, 2026

    Report

    Report Number
    0001649390-2026-00331
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    February 19, 2026
    Report Date
    April 8, 2026
    Manufacturer
    TORNIER INC
    Product Code
    PKC
    UDI-DI
    00846832092185
    PMA / PMN Number
    K220418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    SUBJECT: (B)(6). PHS STUDY. (B)(6) 2026. TRAUMATIC FALL. PARTICIPANT SUSTAINED A FALL ON SHOULDER WHILE WALKING DOG. X-RAY AND MUSCULOSKELETAL ULTRASOUND FINDINGS DEMONSTRATE INTACT SOFT TISSUE AND NO RELATIVE CHANGES TO IMPLANT. THEY REPORT INCREASED PAIN SINCE FALL. (B)(6) 2026. PARTICIPANT WAS DRYING HAIR AND FELT "SNAP" IN SHOULDER WITH EXCRUCIATING PAIN. PHYSICAL EXAM NEGATIVE FOR SOFT TISSUE DAMAGE. WILL REPEAT MSK ULTRASOUND ON (B)(6) 2026 IF PAIN PERSISTS. UPDATE #2 ((B)(6) 2026) REPEAT MUSCULOSKELETAL ULTRASOUND NEGATIVE FOR SOFT TISSUE DAMAGE OR DEVICE ISSUES. AN UNRECOGNIZABLE MASS IS PRESENT BETWEEN LESSER AND GREATER TUBEROSITIES. UPDATE 3 ((B)(6) 2026): CT FINDINGS AND SURGERY. NOT RELATED TO DEVICE/POSSIBLY RELATED TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120576 PERFORM NUCLEUS FC SIZE 2 - ANATOMIC PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL SYSTEM PKC TORNIER INC 00846832092185

    Patients

    Seq Age Sex Outcome Treatment
    1