BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 25200752 · Received May 18, 2026

    Report

    Report Number
    3008021110-2026-00208
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 18, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    UDI-DI
    08033390102940
    PMA / PMN Number
    K142139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY PRE-EXISTING NON-CONFORMITY THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY OCCURRED ON (B)(6) 2023 FOR A REVERSE TOTAL SHOULDER ARTHROPLASTY, WITH FOLLOWING COMPONENTS: - SMR TT BASEPLATE SMALL-R (PN 1375.15.605), - SMR GLENOID PEG TT SMALL-R #MEDIUM (PN 1375.14.652), - CONNECTOR LAR +2MM SMALL-R (PN 1374.15.312), - GLENOSPHERE DIA40MM (PN 1374.09.121, LOT 2213444, STERILIZATION (B)(4)), - FINNED STEM SHORT DIA25MM (PN 1304.15.025), - 140° REVERSE HUMERAL BODY (PN 1352.15.011). - REVERSE LINER +6MM DIA40MM (PN 1365.50.820, LOT 22AT0WC, STERILIZATION (B)(4)). AROUND 3 YEARS AFTER PREVIOUS SURGERY, PATIENT DISLOCATED. PRE-EXISTING CONNECTOR, GLENOSPHERE, REVERSE HUMERAL BODY AND LINER WERE REMOVED AND REPLACED WITH A MORE LATERALIZED AND THICK ASSEMBLY CONSISTING OF: - CONNECTOR LAT +4MM (PN 1374.15.314), - GLENOSPHERE ECCENTRICAL DIA 40MM (PN 1376.09.041), - 140° REVERSE HUMERAL BODY (PN 1352.15.011), - EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001), - REVERSE LINER +6MM DIA40MM (PN 1365.50.820). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1953. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384055 SMR SHOULDER REVERSE LINER 40MM +6MM PHX LIMACORPORATE S.P.A 1365.50.820 22AT0WC 08033390102940

    Patients

    Seq Age Sex Outcome Treatment
    1