BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 24444030 · Received February 25, 2026

    Report

    Report Number
    3008021110-2026-00151
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    February 4, 2026
    Report Date
    April 15, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390270786
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE DHRS AND STERILIZATION CHARTS FOR THE INVOLVED LOT NUMBERS WAS COMPLETED AND DID NOT REVEAL ANY PRE EXISTING ANOMALIES. THE DHR CHECK FOR LOT NUMBER 2119081 HAS BEEN REQUESTED FROM THE THIRD PARTY SUPPLIER AND IS CURRENTLY ONGOING. A FINAL REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    INITIAL REPORT (B)(4). REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO INFECTION. THE IMPLANTED DEVICES WERE REMOVED AND SPACER INSERTED WHILE INFECTION RESOLVES. PREVIOUS SURGERY PERFORMED ON (B)(6) 2022. THE FOLLOWING DEVICES WERE EXPLANTED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.150, LOT: 2119081 - STER: (B)(6)) - SOLD IN US. SMR REVERSE HUMERAL BODY (PRODUCT CODE: 1352.20.010, LOT:2124103 - STER: (B)(6)) - NOT SOLD IN US SMR REVERSE HP LINER LONG (PRODUCT CODE: 1362.09.020, LOT: 2116715 - STER: (B)(6)) - SOLD IN US SMR CONNECTOR SMALL R (PRODUCT CODE: 1374.15.305, LOT: 2201510 - STER: 2200042) - SOLD IN US SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE: 1374.50.440, LOT: 2122191 - STER: (B)(6)) - SOLD IN US SMR UNCEMENT. GLENOID #SMALL-R (PRODUCT CODE: 1375.20.005, LOT: 2124096 - STER: (B)(6)) - NOT SOLD IN US BONE SCREW Ø6,5 H.25MM (PRODUCT CODE: 8420.15.020, LOT: 2024416 - STER: (B)(6)) - SOLD IN US BONE SCREW Ø6,5 H.30MM (PRODUCT CODE: 8420.15.030, LOT:2106481 - STER: (B)(6)) - SOLD IN US PATIENT IS A FEMALE, 60 YEARS OLD. EVENT OCCURRED IN CANADA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624663 SMR SYSTEM SMR SYSTEM - FINNED STEM DIA. 15 MM L. 80 MM HSD LIMACORPORATE S.P.A. 1304.15.150 2119081 08033390270786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other