BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVER. LINER RETENTIVE STD

    MDR report key: 20179551 · Received September 10, 2024

    Report

    Report Number
    3008021110-2024-00071
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 10, 2024
    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 CHARTS OF THE COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DISCOVERED ON THE ITEMS MANUFACTURED WITH THE SAME LOT NUMBERS. ACCORDING TO OUR RECORDS, AT LEAST 22 OUT OF (B)(4) ITEMS BELONGING TO THE LOT NUMBER 18AT2CY AND STERILIZATION 1900230 HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. NEITHER REMOVED COMPONENTS NOR RADIOGRAPHIES ARE AVAILABLE TO BE SHARED AND ANALYSIS. HOWEVER, ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE PATIENT'S BONE QUALITY WAS POOR DUE TO DIALYSIS. THE CHOICE TO IMPLANT CEMENTLESS COMPONENTS, DESPITE THE POOR BONE QUALITY, WAS MADE BY THE SURGEON BECAUSE THE PATIENT IS NOT MOBILE AND IN END-OF-LIFE CARE. THE PATIENT COMPLAINED ABOUT PAINT SINCE THE PRIMARY SURGERY ON (B)(6) AND THE SURGEON BELIEVED THIS WAS THE BEST OPTION. THEREFORE, CONSIDERING THAT: - NO PRE-EXISTING ANOMALY HAS BEEN FOUND ON THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE EVENT - BASED ON THE INFORMATION RECEIVED, THE PATIENT HAS A POOR BONE QUALITY DUE TO DIALYSIS. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA ACCORDING TO THE RELEVANT PMS DATA, THE REVISION RATE OF SMR REVERSE LINERS, BELONGING TO THE FAMILY PRODUCT CODES 1360.50.XXX, 1361.50.XXX, 1365.50.XXX, DUE TO LOOSENING OR INSTABILITY IS AROUND 0.03%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL REPORT.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO LOOSENING AND INSTABILITY. IMPLANTS CAME OUT OF POSITION AND THE FOLLOWING COMPONENTS PREVIOUSLY IMPLANTED WERE REMOVED: - SMR REVER. LINER RETENTIVE STD (PART CODE 1361.50.810, LOT NUMBER 18AT2CY, STERILIZATION 1900230). - SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2210281, STERILIZATION 2200142). - SMR CONNECTOR SMALL STD (PART CODE 1374.15.310, LOT NUMBER 1906306, STERILIZATION 1900146). - BONE SCREW Ø6,5 H.20MM (PART CODE 8420.15.010, LOT NUMBER 2114882, STERILIZATION 2100236). - BONE SCREW Ø6,5 H.30MM (PART CODE 8420.15.030, LOT NUMBER 2321580, STERILIZATION 2300206). THE COMPONENTS WERE REPLACED BY A HEMI PROSTHESIS. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A MALE, 75 YEARS OLD. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226059 SMR REVER. LINER RETENTIVE STD REVERSE LINERS 36MM (UHMWPE) RETENTIVE STD. PHX LIMACORPORATE S.P.A. 1361.50.810 18AT2CY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention