BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22288364 · Received June 18, 2025

    Report

    Report Number
    3008021110-2025-00076
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 18, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390080613
    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 INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE SAME PRODUCT CODES AND LOT NUMBERS AS THE DEVICES HEREBY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINT SOURCE; THEREFORE, NO FURTHER INVESTIGATION CAN BE CARRIED OUT IN THIS EVENT. HOWEVER, TAKING INTO ACCOUNT THAT: CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF THE COMPONENTS INVOLVED IN THIS EVENT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND, THAT COULD HAVE CONTRIBUTED TO THE EVENT. 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 (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 INFECTION. THERE WAS AN INFECTION FROM THE SKIN INCISION, THE SURGEON WANTED TO DO A POLY SWAP. THE FOLLOWING LINER WAS THE ONLY COMPONENT REMOVED AND REPLACED BY A SIMILAR DEVICE: SMR REVERSE LINER STANDARD (PART CODE: 1360.50.810, LOT NUMBER: 22AT1GH, STERILIZATION 2200243). THE OTHER COMPONENTS WERE LEFT IN SITU: SMR METAL-BACK GLENOID SMALL R (PART CODE: 1375.21.005, LOT NUMBER: 2433154, STERILIZATION 2500010) . SMR SMALL-R CONNECTOR +2 (PART CODE: 1374.15.312, LOT NUMBER: 2500708, STERILIZATION 2500041). SMR GLENOSPHERE DIA. 36MM (PART CODE: 1374.09.111, LOT NUMBER: 2436656, STERILIZATION 2500015). FINNED REVERSE HUM. BODY 140° (PART CODE: 1352.15.051, LOT NUMBER: 2416428, STERILIZATION 2400165). SMR CEMENTLESS FINNED STEM (PART CODE: 1304.15.140, LOT NUMBER: 2312939, STERILIZATION 2300232). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1969. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911621 SMR SHOULDER REVERSE LINERS 36MM (UHMWPE) STANDARD PHX LIMACORPORATE S.P.A. 1360.50.810 22AT1GH 08033390080613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention