BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER SYSTEM

    MDR report key: 22876651 · Received August 22, 2025

    Report

    Report Number
    3008021110-2025-00109
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 15, 2025
    Report Date
    September 1, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390272575
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS, NO PRE-EXISTING ANOMALIES WERE FOUND IN THE 42 ITEMS BELONGING TO THE LOT NUMBER 2432605 AND STERILIZATION NUMBER (B)(4). THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS, NO PRE-EXISTING ANOMALIES WERE FOUND IN THE 42 ITEMS BELONGING TO THE LOT NUMBER 2432605 AND STERILIZATION NUMBER (B)(4). THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. WE TRIED TO RECOVER ADDITIONAL INFORMATION ABOUT THE EVENT, BUT NO OTHER DETAILS ARE AVAILABLE. HOWEVER, ACCORDING TO THE REPORT RECEIVED BY THE COMPLAINT SOURCE, THE SURGEON THINKS HE DIDN'T TIGHTEN THE BOLT DOWN ENOUGH WHILE IMPLANTING. HENCE, CONSIDERING THAT: - NO PRE-EXISTING ANOMALIES WERE FOUND BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBER 2432605 AND STERILIZATION (B)(4) - BASED ON THE INFORMATION RECEIVED FROM THE COMPLAINT SOURCE, THE REASON FOR THE REVISION COULD BE RELATED TO A SURGICAL ERROR. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA BASED ON THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR REVERSE HUMERAL BODIES BELONGING TO THE FAMILY PRODUCT CODES 1352.15.0XX-1352.20.XXX DUE TO DISASSEMBLY OF COMPONENTS IS LOWER THAN (B)(4). 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 FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISASSEMBLY OF COMPONENTS. THE HUMERAL BODY DETACHED FROM THE STEM. THE SURGEON THINKS HE DIDN'T TIGHTEN THE BOLT DOWN ENOUGH. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED BY NEW ONES: SMR REVERSE FINNED HUMER. BODY (PART CODE 1352.15.050, LOT NUMBER 2432605, STERILIZATION (B)(4). SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.816, LOT NUMBER 23AT1TE, STERILIZATION (B)(4). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. DURING THIS SURGERY, THE FOLLOWING COMPONENTS WERE IMPLANTED, TOGETHER WITH THOSE REMOVED IN REVISION (ABOVE MENTIONED): SMR METAL-BACK GLENOID SMALL R (PART CODE 1375.21.005, LOT NUMBER 2435105, STERILIZATION (B)(4). SMR ECCENT. GLENOSPHERE Ø 40MM (PART CODE 1376.09.041, LOT NUMBER 1903686, STERILIZATION (B)(4). SMR SMALL-R CONNECTOR +4 (PART CODE 1374.15.314, LOT NUMBER 2114865, STERILIZATION (B)(4). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1960. THE EVENT HAPPENED IN THE UNITED STATES.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6)2025, DUE TO DISASSEMBLY OF COMPONENTS. THE HUMERAL BODY DETACHED FROM THE STEM. THE SURGEON THINKS HE DIDN'T TIGHTEN THE BOLT DOWN ENOUGH. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED BY NEW ONES: - SMR REVERSE FINNED HUMER. BODY (PART CODE 1352.15.050, LOT NUMBER 2432605, STERILIZATION (B)(4)) - SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.816, LOT NUMBER 23AT1TE, STERILIZATION (B)(4)) PREVIOUS SURGERY TOOK PLACE ON APRIL 1ST, 2025. DURING THIS SURGERY, THE FOLLOWING COMPONENTS WERE IMPLANTED, TOGETHER WITH THOSE REMOVED IN REVISION (ABOVE MENTIONED): - SMR METAL-BACK GLENOID SMALL R (PART CODE 1375.21.005, LOT NUMBER 2435105, STERILIZATION (B)(4)) - SMR ECCENT. GLENOSPHERE Ø 40MM (PART CODE 1376.09.041, LOT NUMBER 1903686, STERILIZATION (B)(4)) - SMR SMALL-R CONNECTOR +4 (PART CODE 1374.15.314, LOT NUMBER 2114865, STERILIZATION (B)(4)) THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1960. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619554 SMR SHOULDER SYSTEM FINNED REVERSE HUMERAL BODY FOR TRAUMA PHX LIMACORPORATE S.P.A. 1352.15.050 2432605 08033390272575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention