BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 24362075 · Received February 17, 2026

    Report

    Report Number
    3008021110-2026-00110
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    December 17, 2025
    Report Date
    February 17, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    UDI-DI
    08033390080637
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING AND STERILIZATION RECORDS DID NOT IDENTIFY ANY PRE-EXISTING ANOMALY OR NON-CONFORMITY THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE. THE MANUFACTURER WILL PROVIDE A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO GLENOID COMPONENTS FAILURE. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023 WHEN THE ORIGINAL ASSEMBLY, CONSISTING OF SMR HUMERAL COMPONENTS COUPLED WITH ZIMMERBIOMET VRS CUSTOM GLENOID, WAS IMPLANTED. DURING REVISION THE SURGEON REMOVED THE FAILED GLENOID COMPONENTS, AND REPLACED THE SMR REVERSE HUMERAL BODY (PN 1352.15.010, LOT 2222575, STERILIZATION, (B)(4) AND SMR REVERSE LINER +6 MM (PN 1360.50.820, LOT 19AT06N, STERILIZATION (B)(4)) WITH ADAPTOR TAPER NEUTRAL (PN 1330.15.270), HUMERAL BODY TRAUMA LONG (PN 1350.15.020) AND CTA HEAD DIA54MM (PN 1323.09.540) TO CONVERT THE REVERSE PROSTHESIS TO AN ANATOMIC CONFIGURATION. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1954. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423577 SMR SHOULDER REVERSE LINERS 36MM (UHMWPE) +6MM PHX LIMACORPORATE S.P.A 1360.50.820 19AT06N 08033390080637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention