BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER SYSTEM

    MDR report key: 25280182 · Received May 26, 2026

    Report

    Report Number
    3008021110-2026-00225
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390268240
    PMA / PMN Number
    K201905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PRODUCTION AND STERILIZATION RECORDS FOR COMPLAINED COMPONENT HAS BEEN PERFORMED AND DID NOT HIGHLIGHT ANY PRE-EXISTING 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 UNDERLYING INFECTION, CHRONIC INSTABILITY AND CONSEQUENT DISLOCATION. 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 (B)(6) 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 OCCURRED ON (B)(6) 2026, DUE TO UNKNOWN REASONS, AND HUMERAL BODY AND GLENOID COMPONENTS, EXCEPT FOR THE BASEPLATE, HAS BEEN EXPLANTED (MFR # 3008021110-2026-00242) AND REPLACED. THEREFORE, AT THE TIME OF THE FOURTH REVISION SURGERY, HEREBY REPORTED, THE IMPLANT WAS CONSISTING OF: STEM ORIGINALLY IMPLANTED 140° HUMERAL BODY REVERSE (PN 1352.15.015, LOT. 2430583, STER. (B)(4); REVERSE LINER RETENTIVE +3MM DIA 40 MM (PN 1365.54.816, LOT. 23AT3V4, STER. (B)(4); ECCENTRICAL GLENOSPHERE DIA. 40 MM (PN 1376.09.041, LOT. 2533219, STER. (B)(4); SMR CONNECTOR SMALL R (PN 1374.15.305, LOT. 2501812, STER. (B)(4); CONNECTOR LAT. +4MM + SCREW (PN 1374.15.314, LOT. 2538727, STER. (B)(4); TT BASEPLATE SMALL-R (PN 1375.15.605, LOT. 2521451, STER. (B)(4) - IMPLANTED DURING SECOND REVISION OCCURRED ON (B)(6) 2026. BONE SCREW Ø6,5 H.30MM (PN 8420.15.030, LOT. 2328630, STER. (B)(6); BONE SCREW Ø6,5 H.40MM (PN 8420.15.050, LOT. 2023229, STER. (B)(6). CENTRAL POST DURING THE SURGERY ALL ABOVE MENTIONED COMPONENTS HAVE BEEN EXPLANTED. SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH MAY (B)(6)1962. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417308 SMR SHOULDER SYSTEM 140° SHORT REVERSE HUMERAL BODY PHX LIMACORPORATE S.P.A. 1352.15.015 2430583 08033390268240

    Patients

    Seq Age Sex Outcome Treatment
    1