BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 13730227 · Received March 11, 2022

    Report

    Report Number
    3008021110-2022-00013
    Event Type
    Injury
    Date Received
    March 11, 2022
    Date of Event
    February 25, 2022
    Report Date
    June 24, 2022
    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 WAS FOUND ON THE COMPONENTS THAT WERE RELEASED ON THE MARKET WITH THE SAME LOT #S. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND. THEREFORE, THE PRODUCTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED - DATED SEPTEMBER 2021 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE RADIOGRAPHS LOOK UNREMARKABLE. THE CLINICAL REASON FOR REVISION WAS INFECTION, NEGATIVE CULTURES DO NOT RULE OUT INFECTION, IT IS THE SURGEON'S DIAGNOSIS THAT COUNTS. I DO NOT SEE ANY IMPLANT RELATED ISSUE HERE. IT IS ALL A FATEFUL CAUSE OF EVENTS". CONSIDERING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S; · NO GROWTH WAS OBSERVED OVER 14 DAYS INCUBATION ON SPECIMEN TAKEN FROM GLENOID COMPONENTS; · ACCORDING TO THE MEDICAL CONSULTANT "THE CLINICAL REASON FOR REVISION WAS INFECTION, NEGATIVE CULTURES DO NOT RULE OUT INFECTION"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE DUE TO INFECTION IS 0.069%. 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

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6), 2022, DUE TO INFECTION. IT WAS REPORTED THAT ALL IMPLANTED COMPONENTS WERE REMOVED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.200, LOT #1908653 - STER. 1900323). SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #2013105 - STER. 2000294) - PRODUCT NOT SOLD IN THE US. SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT #2009844 - STER. 2000220) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #1921914 - STER. 2000039). SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2014685 - STER. 2000265) - PRODUCT NOT SOLD IN THE US. SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #2002260 - STER. 2000079) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2014543 - STER. 2000923). BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #2006390 - STER. 2000206). A TEMPORARY BONE CEMENT WAS PLACED IN. SPECIMEN WERE TAKEN FOR ANALYSIS. ACCORDING TO THE COMPLAINT SOURCE, THE REVISION SURGERY WILL BE PERFORMED ONCE THE INFECTION IS TREATED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS A MALE, (B)(6). EVENT HAPPENED IN (B)(6).

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO INFECTION. IT WAS REPORTED THAT ALL IMPLANTED COMPONENTS WERE REMOVED: · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.200, LOT #1908653 - STER. 1900323) · SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #2013105 - STER. 2000294) - PRODUCT NOT SOLD IN THE US · SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT #2009844 - STER. 2000220) - PRODUCT NOT SOLD IN THE US · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #1921914 - STER. 2000039) · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2014685 - STER. 2000265) - PRODUCT NOT SOLD IN THE US · SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #2002260 - STER. 2000079) - PRODUCT NOT SOLD IN THE US · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2014543 - STER. 2000293) · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #2006390 - STER. 2000206) A TEMPORARY BONE CEMENT WAS PLACED IN. SPECIMEN WERE TAKEN FOR ANALYSIS. ACCORDING TO THE COMPLAINT SOURCE, THE REVISION SURGERY WILL BE PERFORMED ONCE THE INFECTION IS TREATED. NO GROWTH WAS OBSERVED OVER 14 DAYS INCUBATION ON SWABS TAKEN FROM GLENOID COMPONENTS. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS A MALE, 65 YEARS OLD. HE HAS A BMI OF 27.1. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572773 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM HSD LIMACORPORATE S.P.A. 1304.15.200 1908653

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention