BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 21663546 · Received March 21, 2025

    Report

    Report Number
    3008021110-2025-00035
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 21, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390001427
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER 1309283, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT NUMBER 1309283 AND STERILIZATION (B)(4). WE WILL SUBMIT THE FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION DUE TO CUFF FAILURE PERFORMED ON (B)(6) 2025. THE PATIENT HAD SUBSCAPULARIS TEAR, AND THE ANATOMIC TOTAL SHOULDER WAS REVISED TO REVERSE TOTAL SHOULDER. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH REVERSE COMPONENTS: SMR HUMERAL HEAD Ø52 MM (PART CODE 1322.09.520, LOT NUMBER 1309283, STERILIZATION (B)(4)). SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.274, LOT NUMBER 141061, STERILIZATION (B)(4)). SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER 1409544, STERILIZATION (B)(4)). LINER F. MET.BACK GLEN.SMALL (PART CODE 1377.50.020, LOT NUMBER 1407195, STERILIZATION (B)(4)). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2015. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1945. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547014 SMR SHOULDER HUMERAL HEAD HSD LIMACORPORATE S.P.A. 1322.09.520 1309283 08033390001427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention