BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 24696584 · Received March 26, 2026

    Report

    Report Number
    3008021110-2026-00185
    Event Type
    Injury
    Date Received
    March 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWT
    UDI-DI
    08033390274074
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) FOR THE LOT: 1207477 AND STER. 1200230 WAS CONDUCTED. NO PRE-EXISTING ANOMALIES WERE IDENTIFIED AMONG THE (B)(4) DEVICES MANUFACTURED WITHIN THE SAME LOT AND STER. A FINAL REPORT WILL BE SHARED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE PATIENT UNDERWENT REVISION SURGERY DUE TO CUFF FAILURE. INTRAOPERATIVELY, METALLOSIS AND POLYETHYLENE WEAR WERE OBSERVED, LEADING TO THE REMOVAL OF ALL ANATOMIC COMPONENTS AND CONVERSION TO A REVERSE SHOULDER ARTHROPLASTY CONFIGURATION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2013. THE EXPLANTED COMPONENTS INCLUDED: SMR ECC. ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.274, LOT N. 1204235, STER. N. 1200183). SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT N. 1208331, STER. N. 1200327). LINER F. MET. BACK GLEN. SMALL-R (PRODUCT CODE 1377.50.005, LOT N. 1214487, STER. N. 1200390). SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE 1322.09.440, LOT N. 1207477, STER. N. 1200230). PATIENT IS FEMALE, 79 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756594 SMR SYSTEM SMR SYSTEM - HUMERAL HEAD DIA. 44 MM KWT LIMACORPORATE S.P.A 1322.09.440 08033390274074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other