BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 17487294 · Received August 9, 2023

    Report

    Report Number
    3008021110-2023-00100
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    August 2, 2023
    Report Date
    December 6, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WERE FOUND ON THE DEVICES STERILIZED WITH THE SAME LOT #S. THEREFORE, PRODUCTS PLACED ON THE MARKET 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 THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; CLINICAL DATA FOR THE PATIENT; RESULTS OF SPECIMEN ANALYSIS. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. CONSIDERING THAT CHECK OF STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH 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 PROSTHESIS DUE TO INFECTION IS (B)(4). 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 FINAL MDR.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WERE FOUND ON THE DEVICES STERILIZED WITH THE SAME LOT #S. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO INFECTION. ALL IMPLANTS WERE REMOVED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, LOT #2103237 - STER. 2100099). SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #2024179 - STER. 2100038). SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #2105019 - STER. 2100136) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2107186 - STER. 2100158). SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2107672 - STER. 2100153) - PRODUCT NOT SOLD IN THE US. SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2107322 - STER. 2100180) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2108139 - STER. 2100163). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2108139 - STER. 2100163). A CEMENTED SPACER WAS INSERTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A FEMALE, 63 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO INFECTION. ALL IMPLANTS WERE REMOVED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, LOT #2103237 - STER. 2100099) SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #2024179 - STER. 2100038). SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #2105019 - STER. 2100136) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2107186 - STER. 2100158). SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2107672 - STER. 2100153) - PRODUCT NOT SOLD IN THE US. SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2107322 - STER. 2100180) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2108139 - STER. 2100163). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2108139 - STER. 2100163). A CEMENTED SPACER WAS INSERTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A FEMALE, 63 YEARS OLD. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588015 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM HSD LIMACORPORATE S.P.A. 1304.15.180 2103237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention