BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 23200355 · Received October 2, 2025

    Report

    Report Number
    3008021110-2025-00123
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 12, 2025
    Report Date
    October 2, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    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 OF THE COMPONENTS REMOVED IN THE REVISION SURGERY HEREBY REPORTED, NO PRE-EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS EVENT HAS BEEN DISCOVERED. SINCE THE STERILIZATION NUMBER OF THE STEM IS UNKNOWN, WE CHECKED ALL THE STERILIZATION NUMBERS THAT HAVE BEEN ASSOCIATED WITH THE LOT NUMBER 1804453, WITHOUT FINDING ANY PRE-EXISTING ANOMALY. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS EVENT; THEREFORE, WE ARE NOT ABLE TO CARRY OUT ANY FURTHER INVESTIGATION. HOWEVER, TAKING INTO ACCOUNT THAT: - NO PRE-EXISTING ANOMALIES HAVE BEEN IDENTIFIED BY CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF THE COMPONENTS INVOLVED IN THIS EVENT WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: ACCORDING TO THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR REVERSE HUMERAL BODIES BELONGING TO THE FAMILY PRODUCT CODES 1352.15.0(B)(6) - 1352.20.(B)(6) DUE TO INFECTION IS AROUND (B)(4). BASED ON THE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS 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

    REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INFECTION. ALL THE FOLLOWING IMPLANTS WERE REMOVED, AND A SPACER WAS IMPLANTED: - SMR CEMENTL. REV. STEM Ø13 MM (PART CODE 1308.15.136, LOT NUMBER 1804453, STERILIZATION UNKNOWN). - SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2024181, STERILIZATION (B)(4)). - SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 20AT1H3, STERILIZATION (B)(4)). - SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 1918626, STERILIZATION (B)(4)) - SMR SMALL-R CONNECTOR +2 (PART CODE 1374.15.312, LOT NUMBER 2008543, STERILIZATION (B)(4)). - SMR GLENOID PEG TT SMALL-R #M (PART CODE 1375.14.652, LOT NUMBER 2010971, STERILIZATION (B)(4)). - SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 2010998, STERILIZATION (B)(4)). PREVIOUS SURGERY DATE IS UNKNOWN. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1953. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319730 SMR SHOULDER REVERSE HUMERAL BODY FOR ELECTIVE SURGERY PHX LIMACORPORATE S.P.A. 1352.15.010 2024181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention