BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER SYSTEM

    MDR report key: 25134379 · Received May 11, 2026

    Report

    Report Number
    3008021110-2026-00203
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 7, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390000963
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) AND THE STERILIZATION CHARTS FOR THE INVOLVED LOT NUMBERS WAS PERFORMED AND DID NOT REVEAL ANY PRE-EXISTING ANOMALY. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DUE TO INFECTION. DURING THE REVISION SURGERY SHOULDER REVERSE CONFIGURATION CONSISTING OF LIMA HUMERAL COMPONENTS AND DJO GLENOID COMPONENTS HAS BEEN CONVERTED INTO AN ANATOMIC CONFIGURATION COMPOSED BY DJO COMPONENTS ONLY. FOLLOWING PRE-EXISTING LIMA COMPONENTS HAVE BEEN EXPLANTED: SMR CEMENTLESS FINNED STEM (PN 1304.15.220, LOT. 2220341, STER. (B)(6); SMR HUMERAL EXTENSION + 9 MM (PN 1352.15.001, LOT. 2429616, STER. (B)(6); FINNED REVERSE HUM. BODY 140° (PN 1352.15.051, LOT. 2516852, STER. (B)(6); SMR REV. LINER RETENTIVE +6 MM (PN 1361.50.820, LOT. 24AT4LP, STER. (B)(6). SURGERY HAS BEEN COMPLETED AS INTENDED. PREVIOUS SURGERY OCCURRED ON (B)(6) 2026. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1956. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4943 SMR SHOULDER SYSTEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.22MM HSD LIMACORPORATE S.P.A. 1304.15.220 2220341 08033390000963

    Patients

    Seq Age Sex Outcome Treatment
    1