BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER SYSTEM

    MDR report key: 25200761 · Received May 18, 2026

    Report

    Report Number
    3008021110-2026-00210
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 18, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390002608
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING AND STERILIZATION RECORD DID NOT HIGHLIGHT ANY ANOMALY ON INVOLVED BATCHES. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO INFECTION. DURING THE REVISION ALL PRE-EXISTING COMPONENTS HAS BEEN EXPLANTED: SMR CEMENTLESS FINNED STEM (PN 1304.15.200, LOT. 2102987, STER. 2100108); SMR HUMERAL HEAD D.48 H.16MM (PN 1321.09.481, LOT. 2101790, STER. 2100079); SMR ECC.ADAPTOR TAPER STANDARD (PN 1330.15.274, LOT. 2115996, STER. 2100280); SMR FINNED HUMERAL BODY (PN 1350.15.110, LOT. 2114697, STER. 2100274); SMR METAL-BACK GLENOID STD (PN 1375.21.010, LOT. 2100627, STER. 2100093); LINER F.MET.BACK GLEN.STANDARD (PN 1377.50.010, LOT. 21AT1AA, STER. 2100306); BONE SCREW Ø6,5 H.30MM (PN 8420.15.030, LOT. 2120657, STER. 2100314); BONE SCREW Ø6,5 H.30MM (PN 8420.15.030, LOT. 2121636, STER. 2100334). AND FOLLOWING NEW COMPONENTS HAVE BEEN IMPLANTED: FINNED STEM DIA. 21MM L.80MM (PN 1304.15.210); FINNED HUMERAL BODY MEDIUM (PN 1350.15.110); ECCENTRICAL 4MM ADAPTOR TAPER (PN 1330.15.274); HUMERAL HEAD DIA. 50 H. 21MM (PN 1324 .09.501). SURGERY HAS BEEN COMPLETED AS INTENDED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021. PATIENT IS FEMALE, DATE OF BIRTH: (B)(6)1953. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297989 SMR SHOULDER SYSTEM LINER FOR METAL-BACK (UHMWPE) LINER STANDARD PHX LIMACORPORATE S.P.A. 1377.50.010 21AT1AA 08033390002608

    Patients

    Seq Age Sex Outcome Treatment
    1