BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 14944098 · Received July 7, 2022

    Report

    Report Number
    3008021110-2022-00062
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    June 29, 2022
    Report Date
    July 7, 2022
    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 COMPONENTS PROCESSED WITH THOSE STERILIZATION #S. THEREFORE, ALL THE PRODUCTS WITH THOSE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE AND POST-OPERATIVE X-RAYS OF THE REVISION SURGERY WERE REQUESTED TO THE COMPLAINT SOURCE, HOWEVER THEY WERE NOT AVAILABLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED BY THE INVOLVED STERILIZATION NUMBERS, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION IS 0.070%. 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 PROSTHESIS PERFORMED ON (B)(6) 2022 DUE TO INFECTION AND LOOSENING. IT WAS REPORTED THAT THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS STREPTOCOCCUS. ALL COMPONENTS HAVE BEEN REMOVED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.210, LOT #1402657 - STER. 2000042). SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #2117892 - STER. 2100292). SMR REVERSE HP LATERALIZING LINER MEDIUM (PRODUCT CODE 1362.09.115, LOT #2123407 - STER. 2200002) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2025211 - STER. 2100084). SMR REVERSE HP GLENOSPHERE 44 MM (PRODUCT CODE 1374.50.440, LOT #2123531 - STER. 2100332) - PRODUCT NOT SOLD IN THE US. SMR UNCEMENTED GLENOID # SMALL (PRODUCT CODE 1375.20.020, LOT #2118664 - STER. 2100316) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2122801 - STER. 2100340). BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #2016866 - STER. 2000322) A CEMENT SPACER WAS INSERTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A MALE. IT WAS REPORTED THAT PATIENT HAS HIGH BMI AND PERFORMS LOW ACTIVITY LEVEL. ACCORDING TO THE COMPLAINT SOURCE HE'S A SMOKER AND UNHEALTHY WITH COMORBIDITIES. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2672301 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.21MM HSD LIMACORPORATE S.P.A. 1304.15.210 1402657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention