BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 17304879 · Received July 12, 2023

    Report

    Report Number
    3008021110-2023-00085
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    April 3, 2023
    Report Date
    July 12, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICES. THEREFORE, THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE PATHOGEN RESPONSIBLE FOR THE INFECTION AND ANY PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE ACCESSIBLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS DUE TO INFECTION IS 0.076%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS 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 MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON APRIL 3RD, 2023, DUE TO IMPLANT LOOSENING. LOOSENING WAS OBSERVED ON THE HUMERAL SIDE ONLY. IT WAS REPORTED THAT PATIENT FELT PAIN AND INSTABILITY. THE WHOLE PROSTHESIS WAS EXPLANTED, WITH THE EXEMPTION OF THE GLENOID METALBACK, WHICH WAS WELL FIXED AND LEFT IN-SITU: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.170, LOT #1906841 - STER. 1900226), SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #1907049 - STER. 1900191), SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1362.09.015, LOT #1903716 - STER. 1900188) - PRODUCT NOT SOLD IN THE US, SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #1910384 - STER. 1900246), SMR REVERSE HP GLENOSPHERE 44 MM (PRODUCT CODE 1374.50.440, LOT #1908020 - STER. 1900208) - PRODUCT NOT SOLD IN THE US, BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #1904905 - STER. 1900124), BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #1911957 - STER. 1900291) NO DEVICE WAS IMPLANTED. DURING THE REVISION SURGERY, SURGEON QUESTIONED ABOUT INFECTION, AND SENT SOME SAMPLES FOR CULTURE. SAMPLES CAME BACK POSITIVE, HOWEVER THE DETAILS ON THE PATHOGEN ARE UNKNOWN. SECOND STAGE PROCEDURE WAS PERFORMED ON (B)(6) 2023, AND NEW DEVICES WERE PLACED IN. IT WAS CONFIRMED THAT PREVIOUS REVISION WAS DUE TO SEPTIC LOOSENING. THE SURGEON KEEPS MONITORING THE PATIENT FOR INFECTION. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2019. PATIENT IS A MALE, 66 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748920 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.17MM HSD LIMACORPORATE S.P.A. 1304.15.170 1906841

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention