BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERIS

    MDR report key: 23125875 · Received September 23, 2025

    Report

    Report Number
    3014128390-2025-00057
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 13, 2025
    Report Date
    September 23, 2025
    Manufacturer
    FX SHOULDER SOLUTIONS DALLAS
    Product Code
    HSD
    PMA / PMN Number
    K123814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STERILITY ISSUE OCCURRED WHICH INVOLVED THE PACKAGING BEING COMPROMISED DUE TO A SHIPPING ISSUE. CAPA-2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IN A CASE WITH THE SURGEON ON (B)(6)2025, THE REPRESENTATIVE OPENED TWO 48X19 OFFSET HEADS AND DISCOVERED THAT BOTH HAD DAMAGED INNER PLASTIC TRAYS. IN EACH CASE, THE SIDE WALL WAS SHATTERED. THE INNERMOST PLASTIC WRAPPING WHICH PRESERVES THE STERILITY OF THE IMPLANTS APPEARS TO BE UNCOMPROMISED. THERE WAS MINIMAL SURGICAL DELAY FOR THE REPRESENTATIVE TO PREPARE MORE HEADS, AND THE CASE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATION. CAPA-2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195726 HUMERIS SHOULDER PROSTHESIS HSD FX SHOULDER SOLUTIONS DALLAS P1029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PART: 106-4800 LOT: P1655.