BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 22115063 · Received May 30, 2025

    Report

    Report Number
    3008021110-2025-00066
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    April 28, 2025
    Report Date
    May 30, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390273602
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING AND STERILIZATION CHARTS, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE SAME PART CODES AND LOT NUMBERS AS THE COMPONENTS INVOLVED IN THIS EVENT. ACCORDING TO THE AVAILABLE RECORDS, THIS IS THE FIRST AND ONLY COMPLAINTS RECEIVED ON THOSE LOT NUMBERS. NEITHER REMOVED DEVICES, NOR X-RAYS AND ADDITIONAL INFORMATION ON THE PATHOGEN INVOLVED IN THE INFECTION ARE AVAILABLE TO BE SHARED WITH THE MANUFACTURER. THEREFORE, NO FURTHER INVESTIGATION CAN BE CARRIED OUT ON THIS CASE. HOWEVER, TAKING INTO ACCOUNT THAT: NO PRE-EXISTING ANOMALIES WERE FOUND ON THE ITEMS BELONGING TO THE SAME PART CODES AND LOT NUMBERS AS THE DEVICES INVOLVED IN THIS EVENT, BY CHECKING THE MANUFACTURING AND STERILIZATION CHARTS. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT-RELATED. PMS DATA: BASED ON THE RELEVANT PMS DATA, THE REVISION RATE OF THE SMR REVERSE LINERS BELONGING TO THE FAMILIES 1360.50.XXX, 1361.50.XXX, 1365.50.XXX DUE TO INFECTION IS AROUND 0.06%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INFECTION. THE FOLLOWING GLENOSPHERE, CONNECTOR AND REVERSE LINER WERE REMOVED AND REPLACED BY NEW COMPONENTS: SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 24AT5P7, STERILIZATION (B)(4)). SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2432923, STERILIZATION (B)(4)). SMR ECCENT. GLENOSPHERE Ø 36MM (PART CODE 1376.09.031, LOT NUMBER 2434937, STERILIZATION (B)(4)). THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU: SMR CEMENTLESS MINI STEM (PART CODE 1304.15.120, LOT NUMBER 2223142, STERILIZATION (B)(4)). SMR REVERSE HUMERAL BODY SHORT (PART CODE 1352.15.005, LOT NUMBER 2435343, STERILIZATION (B)(4)). SMR METAL-BACK GLENOID SMALL R (PART CODE 1375.21.005, LOT NUMBER 2426024, STERILIZATION (B)(4)). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A FEMALE, 52 YEARS OLD. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35737 SMR SYSTEM SMR SYSTEM - REVERSE LINER +3MM PHX LIMACORPORATE S.P.A. 1360.50.815 24AT5P7 08033390273602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention