BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER SYSTEM

    MDR report key: 25278964 · Received May 26, 2026

    Report

    Report Number
    3008021110-2026-00242
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390268257
    PMA / PMN Number
    K201905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PRODUCTION RECORDS FOR INVOLVED COMPONENT HAS BEEN PERFORMED AND DID NOT HIGHLIGHT ANY ANOMALY NOR NON-CONFORMITY. A FINAL REPORT WILL BE SUBMITTED AS SOON AS INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY HEREBY REPORTED HAS BEEN PERFORMED ON (B)(6) 2026, DUE TO UNKNOWN REASONS. PATIENT WAS ORIGINALLY IMPLANTED WITH SMR REVERSE PROSTHESIS. ORIGINAL PROSTHETIC ASSEMBLY CONSISTED OF BASEPLATE, LATERALIZED CONNECTOR +4MM, GLENOSPHERE ECCENTRIC DIA 40MM AND SMR HUMERAL BODY REVERSE (PART NUMBER 1352.15.010, LOT UNKNOWN). 9/10 YEARS LATER, FIRST REVISION SURGERY OCCURRED ((B)(6) 2025) DUE TO INFECTION: HUMERAL BODY HAS BEEN EXPLANTED AND REPLACED WITH A NEW ONE (COMPLAINT ASSOCIATED TO MFR # 3008021110-2026-00010). ON JANUARY 21ST, 2026, SECOND REVISION SURGERY HAS BEEN PERFORMED DUE TO UNKNOWN REASONS (MFR # 3008021110-2026-00241) AND PRE-EXISTING HUMERAL BODY AND GLENOID COMPONENTS HAS BEEN EXPLANTED AND REPLACED WITH NEW ONES. A THIRD REVISION SURGERY, HEREBY REPORTED, OCCURRED ON (B)(6) 2026, AND PRE-EXISTING HUMERAL BODY AND GLENOID COMPONENTS EXCEPT FOR THE BASEPLATE HAS BEEN EXPLANTED AND REPLACED, INCREASING ALSO LATERALIZATION. SPECIFICALLY, FOLLOWING COMPONENTS HAVE BEEN EXPLANTED: - 140° HUMERAL BODY FINNED REVERSE (PN 1352.15.051, LOT. 2530378, STER. 2500213); - REVERSE LINER +3MM DIA 40MM (PN 1365.50.815, LOT. 23AT24A, STER. 2400018); - GLENOSPHERE ECCENTRICAL DIA 40MM (PN 1376.09.041, LOT. 2220948, STER. 2200270); - CONNECTOR + SCREW (PN 1374.15.305, LOT. 2501812, STER. 2500045). AND REPLACED WITH: - 140° HUMERAL BODY REVERSE (PN 1352.15.015); - REVERSE LINER RETENTIVE +3MM DIA 40MM (PN 1356.54.816); - GLENOSPHERE ECCENTRICAL DIA 40MM (PN 1376.09.041); - CONNECTOR LAT. +4MM + SCREW (PN 1374.15.314). PATIENT IS MALE, DATE OF BIRTH (B)(6) 1962. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407815 SMR SHOULDER SYSTEM 140° FINNED REVERSE HUMERAL BODY PHX LIMACORPORATE S.P.A. 1352.15.051 2530378 08033390268257

    Patients

    Seq Age Sex Outcome Treatment
    1