BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22923602 · Received August 29, 2025

    Report

    Report Number
    3008021110-2025-00114
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 29, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390116275
    PMA / PMN Number
    K161476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBERS, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE (B)(4) ITEMS BELONGING TO THE LOT NUMBER: 2200831 AND STERILIZATION: 2200070, NOR IN THE (B)(4) ITEMS BELONGING TO THE LOT NUMBER: 2110034 AND STERILIZATION: 2100199. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO BONE FRACTURE. THE PATIENT FRACTURED THE GLENOID IN A PREVIOUS SURGERY AND HAD A HEMI IN. CONVERTED THE HEMI TO A REVERSE, REMOVING THE FOLLOWING COMPONENTS: SMR HUMERAL HEAD D.46 H.15MM (PART CODE: 1321.09.461, LOT NUMBER: 2110034, STERILIZATION: 2100199) PRIMA 2MM ECCENTRICAL ADAPTOR (PART CODE: 1367.15.702, LOT NUMBER: 2200831, STERILIZATION: 2200070) PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. THE PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1948. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164279 SMR SHOULDER HUMERAL HEAD (COCRMO) - DIA.46MM H.15 KWT LIMACORPORATE S.P.A. 1321.09.461 2110034 08033390116275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention