BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 21932973 · Received April 30, 2025

    Report

    Report Number
    3008021110-2025-00040
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    March 24, 2025
    Report Date
    April 30, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390001922
    PMA / PMN Number
    K100858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS BELONGING TO THE SAME PART CODES AND LOT NUMBERS AS THE COMPONENTS REMOVED DURING THE REVISION SURGERY HEREBY REPORTED. WE 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 DISASSEMBLY OF COMPONENTS. THE MORSE TAPER CONNECTION DISENGAGED. THE FOLLOWING COMPONENTS WERE REMOVED: SMR FINNED STEM SHORT D.21 (PART CODE: 1304.15.021, LOT NUMBER: 2016623, STERILIZATION 2000409). SMR HUMERAL HEAD DIA.54 MM (PART CODE: 1322.09.540, LOT NUMBER: 1506372, STERILIZATION 2000414). SMR ECC.ADAPTOR TAPER STANDARD (PART CODE: 1330.15.272, LOT NUMBER: 2331971, STERILIZATION 2400033). SMR FINNED HUMERAL BODY (PART CODE: 1350.15.110, LOT NUMBER: 2101472, STERILIZATION 2100098). THE ABOVE-MENTIONED COMPONENTS WERE REPLACED BY THE FOLLOWING NEW ONES: SMR FINNED STEM DIA 21MM L.80 (PART CODE: 1304.15.210, LOT NUMBER: 2320690, STERILIZATION 2400025). SMR FINNED HUMERAL BODY (PART CODE: 1350.15.110, LOT NUMBER: 2405095, STERILIZATION 2400062). SMR ECC. ADAPTOR TAPER 2MM (PART CODE: 1330.15.272, LOT NUMBER: 2414583, STERILIZATION 2400152). SMR HUMERAL HEAD DIA.54 MM (PART CODE: 1322.09.540, LOT NUMBER: 1503494, STERILIZATION 2000263). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1972. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581714 SMR SHOULDER ECCENTRICAL ADAPTOR TAPERS +2MM, STANDARD KWT LIMACORPORATE S.P.A. 1330.15.272 2331971 08033390001922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention