BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 21966244 · Received May 6, 2025

    Report

    Report Number
    3008021110-2025-00044
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    March 25, 2025
    Report Date
    May 6, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390000888
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE DEVICES INVOLVED, NO PRE-EXISTING ANOMALY WAS FOUND IN THE ITEMS BELONGING TO THE SAME PRODUCT CODES AND LOT NUMBER AS THE COMPONENTS REMOVED. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO POOR BONE QUALITY. THE STEM NEEDED TO BE UPSIZED. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.140, LOT NUMBER 2317201, STERILIZATION (B)(4)). - REVERSE HUMERAL BODY 140° (PART CODE 1352.15.011, LOT NUMBER 2414113, STERILIZATION (B)(4)). - SMR REV. LINER RETENTIVE +6 MM (PART CODE 1361.50.820, LOT NUMBER 20AT1UK, STERILIZATION (B)(4)). - SMR GLENOSPHERE DIA. 36MM (PART CODE 1374.09.111, LOT NUMBER 2433397, STERILIZATION (B)(4)). - SMR SMALL-R CONNECTOR +2 (PART CODE 1374.15.312, LOT NUMBER 2432234, STERILIZATION (B)(4)). THE ABOVE-MENTIONED COMPONENTS WERE REPLACED BY THE FOLLOWING NEW ONES: - SMR SMALL-R CONNECTOR +4 (PART CODE 1374.15.314, LOT NUMBER 2433782, STERILIZATION (B)(4)). - SMR GLENOSPHERE DIA. 40MM (PART CODE 1374.09.121, LOT NUMBER 2432907, STERILIZATION (B)(4)). - SMR FINNED STEM (PART CODE 1304.15.170, LOT NUMBER 2101797, STERILIZATION 2100099). - REVERSE HUMERAL BODY 140° (PART CODE 1352.15.011, LOT NUMBER 2422030, STERILIZATION (B)(4)). - EXTENSION FOR REVERSE HUMERAL BODY (PART CODE 1352.15.001, LOT NUMBER 2431805, STERILIZATION (B)(4)). - SMR REV. LINER RETENTIVE +3 MM (PART CODE 1365.50.816, LOT NUMBER 20AT4V6, STERILIZATION (B)(4)). PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1953. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98183 SMR SHOULDER FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM HSD LIMACORPORATE S.P.A. 1304.15.140 2317201 08033390000888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention