BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 20358668 · Received October 3, 2024

    Report

    Report Number
    3008021110-2024-00077
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    August 30, 2024
    Report Date
    April 5, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    UDI-DI
    08033390002608
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DISCOVERED ON THE ITEMS MANUFACTURED WITH THE SAME LOT NUMBERS. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO DISSOCIATION OF THE LINER. LINER BECAME DISSOCIATED AND REQUIRED REVISION. ACCORDING TO THE INFORMATION REPORTED BY THE AGENT, THE LOCKING MECHANISM ON GLENOID PLASTIC BROKE AT SOME POINT SINCE THE ORIGINAL SURGERY. THE FOLLOWING COMPONENTS PREVIOUSLY IMPLANTED WERE REMOVED: SMR HUMERAL HEAD Ø48 MM (PART CODE 1322.09.480, LOT NUMBER 2009747, STERILIZATION 2000247) SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.276, LOT NUMBER 2002258, STERILIZATION 2000124) LINER F.MET.BACK GLEN.STANDARD (PART CODE 1377.50.010, LOT NUMBER 19AT3YA, STERILIZATION 2000190). THESE COMPONENTS WERE REPLACED BY THE FOLLOWING ONES: SMR HUMERAL HEAD Ø48 MM (PART CODE 1322.09.480, LOT NUMBER 1809667, STERILIZATION 2400044) SMR ECC.ADAPTOR TAPER 4 MM (PART CODE 1330.15.274, LOT NUMBER 2329377, STERILIZATION 2400012). LINER F.MET.BACK GLEN.STANDARD (PART CODE 1377.50.010, LOT NUMBER 19AT1KW, STERILIZATION 1900360). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290728 SMR SHOULDER LINER FOR METAL-BACK (UHMWPE) STANDARD KWS LIMACORPORATE S.P.A. LINER 19AT3YA 08033390002608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention