BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMA TT GLENOID

    MDR report key: 23484043 · Received November 6, 2025

    Report

    Report Number
    3008021110-2025-00138
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 5, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBF
    UDI-DI
    08033390231060
    PMA / PMN Number
    K222427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF THE COMPONENTS INVOLVED IN THIS EVENT, NO PRE-EXISTING ANOMALY, THAT COULD HAVE CONTRIBUTED TO THE EVENT, WAS DISCOVERED IN THE ITEMS BELONGING TO THE SAME PART CODES AND LOT NUMBERS AS THE DEVICES REMOVED IN THE REVISION SURGERY HEREBY REPORTED. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY DUE TO INSTABILITY PERFORMED ON (B)(6) 2025. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE LINER +6MM D.40MM (PART CODE: 1365.50.820, LOT NUMBER: 22AT16B, STERILIZATION: 2200271). PRIMA GLENOSPHERE D.40 MM (PART CODE: 1974.09.040, LOT NUMBER: 2433271, STERILIZATION: 2500004). CONNECTOR W. SCREW LOW LAT.5MM (PART CODE: 1974.15.300, LOT NUMBER: 2320196, STERILIZATION: 2400132). ACCORDING TO THE INFORMATION RECEIVED, THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025, FOR A FRACTURE. THE SECOND REVISION ON (B)(6) 2025, WAS A PLANNED REVISION TO FINISH THE INTENDED CORRECTIONS FROM THE FIRST IMPLANT. THE SURGERY ON (B)(6) 2025 WAS DUE TO THE PATIENT DISLOCATION BECAUSE THE PREVIOUS REVISION DID NOT FULLY STABILIZE THE JOINT. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1945. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551052 PRIMA TT GLENOID PRIMA TT GLENOID GLENOSPHERE DIA. 40MM MBF LIMACORPORATE S.P.A. 1974.09.040 2433271 08033390231060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention