BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22620878 · Received July 25, 2025

    Report

    Report Number
    3008021110-2025-00098
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 25, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBF
    UDI-DI
    08033390123129
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS REMOVED IN THE REVISION SURGERY HEREBY REPORTED, NO PRE-EXISTING ANOMALY WAS FOUND OUT. THE MANUFACTURER WILL SUBMIT THE FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION, PATIENT DISLOCATED AND NEEDED TO BE LATERALIZED. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED BY NEW ONES: - SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.821, LOT NUMBER 24AT0Y0, STERILIZATION 2400221) - SMR GLENOSPHERE Ø 40MM (PART CODE 1374.09.121, LOT NUMBER 2407737, STERILIZATION 2400098) - SMR SMALL/STD CONNECTOR +2 (PART CODE 1374.15.322, LOT NUMBER 2205023, STERILIZATION 2200081) PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025, REGISTERED AS INTERNAL COMPLAINT(B)(4) (AND REPORTED AS MFR. 3008021110-2025-00107). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1942. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660780 SMR SHOULDER GLENOSPHERE DIA. 40 MM MBF LIMACORPORATE S.P.A. 1374.09.121 2407737 08033390123129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention