BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22104992 · Received May 29, 2025

    Report

    Report Number
    3008021110-2025-00050
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 29, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390116268
    PMA / PMN Number
    K161476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOTS: #2126295, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 6 DEVICES MANUFACTURED RESPECTIVELY. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THOSE LOT#S. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. ACCORDING TO THE INFORMATION RECEIVED, AFTER A DETERIORATION OF ROTATOR CUFF, IT WAS ADVISED THAT PATIENT CONVERT TO A REVERSE CONSTRUCT. THE FOLLOWING DEVICES WERE EXPLANTED: SMR HUMERAL HEAD D.44 H.14MM (PRODUCT CODE: 1321.09.441, LOT#: 2126295 - STER. 2200024). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.270, LOT#: 2014099 - STER. UNKNOWN). SMR TRAUMA HUMERAK BODY# LONG (PRODUCT CODE: 1350.15.020, LOT#: 1909580 - STER. 1900265). TT HYBRID CEMENTED GLENOID SMALL (PRODUCT CODE: 1379.59.110, LOT#: 2321146 - STER. 2300202). A 140° REVERSE BODY WAS IMPLANTED WITH A +3 LINER. THE REVISION BASEPLATE WAS IMPLANTED WITH A 36MM GLENOSPHERE. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2023. PATIENT IS A FEMALE, 67 YEARS OLD. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690547 SMR SHOULDER HUMERAL HEAD (COCRMO) - DIA.44MM H.14 HSD LIMACORPORATE S.P.A. 1321.09.441 2126295 08033390116268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention