BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 21993924 · Received May 9, 2025

    Report

    Report Number
    3008021110-2025-00054
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 9, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390002028
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1601336, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 3 DEVICES MANUFACTURED WITH THE SAME LOT # - STER. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THAT LOT #. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC HEMI PROSTHESIS PERFORMED ON (B)(6)2025, DUE TO POOR BONE QUALITY. THIS IS A SECOND STAGE REVISION SURGERY: IT WAS REPORTED THAT THE PATIENT HAD A PRIOR ANATOMIC SHOULDER WITH A CEMENTED 3-PEGGED POLY GLENOID (PRODUCT CODE AND LOT # UNKNOWN). THE PATIENT WAS REVISED AND THE CEMENTED POLY GLENOID WAS REMOVED (DATE OF THE SURGERY UNKNOWN). THE GLENOID WAS PACKED WITH A BONE GRAFT AND LEFT TO HEAL FOR THE SECOND STAGE REVISION. AT THE TIME, AN ANATOMIC HUMERAL BODY AND A HUMERAL HEAD WERE IMPLANTED, AND THE PATIENT WAS LEFT WITH THE HEMI PROSTHESIS. UPON INSPECTION OF THE GLENOID ON THE SURGERY OF (B)(6) 2025, THE BONE QUALITY WAS DEEMED TOO POOR TO PROCEED TO A REVERSE BASEPLATE. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR TRAUMA HUMERAL BODY # SHORT (PRODUCT CODE 1350.15.030, LOT #1601336 - STER. (B)(4)). · SMR HUMERAL HEAD D.44 H.14MM (PRODUCT CODE 1321.09.441, LOT #2014027 - STER. (B)(4)). · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #2014099 - STER. (B)(4)). THE SAME SIZE COMPONENTS WERE PUT BACK IN AND THE PATIENT WILL HAVE A HEMI FOR THE FORESEEABLE FUTURE. PATIENT IS A FEMALE, 81 YEARS OLD. POOR BONE QUALITY REPORTED. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034407 SMR SHOULDER TRAUMA HUMERAL BODIES WITH LOCKING SCREW SHORT HSD LIMACORPORATE S.P.A. HUMERAL BODY 1601336 08033390002028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention