BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 24696583 · Received March 26, 2026

    Report

    Report Number
    3008021110-2026-00186
    Event Type
    Injury
    Date Received
    March 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    HSD
    UDI-DI
    08033390270816
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) FOR THE LOTS AND STER. NUMBERS INVOLVED WAS CONDUCTED. NO PRE-EXISTING ANOMALIES WERE IDENTIFIED AMONG THE DEVICES MANUFACTURED WITHIN THE SAME LOTS AND STER NUMBERS. THIS IS THE ONLY COMPLAINT REGISTERED WITH THESE LOTS. A FINAL MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    TOTAL SMR REVERSE REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO INFECTION. SURGEON MADE INCISION AND DEBRIDED AND COLLECTED TISSUE SAMPLES, THEN PROCEEDED TO DISLOCATE SHOULDER AND BEGIN REMOVING IMPLANTS (WHILE COLLECTING FURTHER TISSUE SAMPLES). SURGEON REMOVED WITH THE LINER, THEN HUMERAL BODY FOLLOWED BY THE GLENOSPHERE, BASEPLATE, SCREWS AND PEG AND FINISHED BY REMOVING THE STEM. THE SURGEON THEN CLOSED UP THE WOUND AND RE GOWNED INTO FRESH OPERATING ATTIRE, RE DRAPED THE PATIENT TO LIMIT THE RISK OF CROSS CONTAMINATION POST REMOVAL OF INFECTED IMPLANTS AND PROCEEDED TO IMPLANT A CEMENT SPACER WITH ANTIBIOTICS. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020. THE EXPLANTED COMPONENTS INCLUDED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, LOT N. 1917922, STER. N. 2000019). SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT N. 2004533, STER. N. 2000167). SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE 1374.50.440, LOT N. 2002433, STER. N. 2000089). SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT N. 1916846, STER. N. 1900433). SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT N. 2005687, STER. N. 2000213). BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT N. 2006404, STER. N. 2000209). BONE SCREW Ø6,5 H.40MM (PRODUCT CODE 8420.15.050, LOT N. 1913765, STER. N. 1900326). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT N. 2006971, STER. N. 2000199). PATIENT IS MALE, 67 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756590 SMR SYSTEM SMR SYSTEM - FINNED STEM DIA. 18 MM L. 80 MM HSD LIMACORPORATE S.P.A 1304.15.180 08033390270816

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other