BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22159543 · Received June 6, 2025

    Report

    Report Number
    3008021110-2025-00071
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 6, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBF
    UDI-DI
    08033390123129
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS, NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED ON THE (B)(4) ITEMS MANUFACTURED WITH THE SAME PRODUCT CODE AND LOT NUMBER AS THE DEVICE REMOVED IN THIS EVENT. ACCORDING TO THE RECORDS AVAILABLE, ALL THE ITEMS BELONGING TO THE PART CODE 1374.09.121, LOT NUMBER 2201768 AND STERILIZATION (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT. WE HAVE RECEIVED NO ADDITIONAL INFORMATION ON THIS EVENT; THEREFORE, WE CANNOT CARRY OUT FURTHER INVESTIGATION. HOWEVER, CONSIDERING THAT: - NO PRE-EXISTING ANOMALY WAS DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBER OF THE COMPONENT INVOLVED IN THE EVENT. - THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: BASED ON THE RELEVANT PMS DATA, THE REVISION RATE OF THE GLENOSPHERES BELONGING TO THE FAMILY CODES (B)(4) 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 LOOSENING. PATIENT PRESENTED WITH A LOOSE HUMERAL COMPONENT. THE FOLLOWING GLENOSPHERE WAS REMOVED AND REPLACED BY A NEW GLENOSPHERE (DIAMETER 42 MM): - SMR GLENOSPHERE DIA. 40MM (PART CODE 1374.09.121, LOT NUMBER 2201768, STERILIZATION (B)(4)). THE DATE OF PREVIOUS SURGERY IS UNKNOWN. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1953. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604282 SMR SHOULDER GLENOSPHERE DIA. 40 MM MBF LIMACORPORATE S.P.A. 1374.09.121 2201768 08033390123129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention