BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 18683525 · Received February 12, 2024

    Report

    Report Number
    3008021110-2024-00015
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    February 6, 2024
    Report Date
    February 8, 2024
    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, PRODUCTS WITH THOSE 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 NO 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 PROSTHESES DUE TO INFECTION IS 0.08%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY 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), 2024, DUE TO INFECTION. THE FOLLOWING COMPONENTS GOT EXPLANTED: · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT #2200369 - (B)(4)) · SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #2212996 - (B)(4)) · SMR REVERSE HP LINER LONG (PRODUCT CODE 1365.09.020, LOT #2208566 - (B)(4)) - PRODUCT NOT SOLD IN THE US · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2214331 - (B)(4)) · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2218275 - (B)(4)) - PRODUCT NOT SOLD IN THE US · SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2214872 - (B)(4)) - PRODUCT NOT SOLD IN THE US · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2210248 - (B)(4)) · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2214084 - (B)(4)). A SPACER WAS IMPLANTED. SWABS WERE TAKEN BUT RESULTS ARE NOT YET AVAILABLE. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A FEMALE, 70 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087643 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM HSD LIMACORPORATE S.P.A. 1304.15.140 2200369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention