BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 23200517 · Received October 2, 2025

    Report

    Report Number
    3008021110-2025-00124
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 13, 2025
    Report Date
    October 2, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBF
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE GLENOID COMPONENTS INVOLVED IN THIS EVENT, NO PRE-EXISTING ANOMALY WAS FOUND IN: THE (B)(4) ITEMS BELONGING TO THE LOT NUMBER 2101115 AND STERILIZATION (B)(4). THE (B)(4) ITEMS BELONGING TO THE LOT NUMBER 2105867 AND STERILIZATION (B)(4). THE (B)(4) ITEMS BELONGING TO THE LOT NUMBER 2104409 AND STERILIZATION (B)(4). THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ABOUT THESE LOT NUMBERS. WE DID NOT RECEIVE ANY ADDITIONAL INFORMATION ABOUT THIS EVENT, THEREFORE WE ARE NOT ABLE TO CARRY OUT ANY FURTHER INVESTIGATION. HOWEVER, TAKING INTO ACCOUNT THAT: NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE GLENOID COMPONENTS INVOLVED IN THIS EVENT. WE DID NOT RECEIVE ANY OTHER COMPLAINTS ON THESE LOT NUMBERS. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: ACCORDING TO THE AVAILABLE PMS DATA, THE OCCURRENCE RATE OF REVISION SURGERIES THAT INVOLVE THE SMR GLENOSPHERES BELONGING TO THE FAMILY PRODUCT CODES 1374.09.XXX - 1376.09.XXX - 1374.15.XXX - 1376.15.XXX DUE TO LOOSENING IS AROUND (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 COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO GLENOID LOOSENING. THE PRODUCTS PREVIOUSLY IMPLANTED WERE THE FOLLOWING: SMR ECCENT. GLENOSPHERE Ø 36MM (PART CODE 1376.09.031, LOT NUMBER 2105867, STERILIZATION (B)(4)). SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 2101115, STERILIZATION (B)(4)). SMR GLENOID PEG TT SMALL-R #S (PART CODE 1375.14.651, LOT NUMBER 2104409, STERILIZATION (B)(4)). SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.160, LOT NUMBER 2023433, STERILIZATION (B)(4)). SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2116733, STERILIZATION (B)(4)). SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 20AT536, STERILIZATION (B)(4)). SMR SMALL-R CONNECTOR +2 (PART CODE 1374.15.312, LOT NUMBER 2108545, STERILIZATION (B)(4)). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1955. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318884 SMR SHOULDER ECCENTRICAL GLENOSPHERE DIA. 36 MM MBF LIMACORPORATE S.P.A. 1376.09.031 2105867

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention