BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 18131378 · Received November 14, 2023

    Report

    Report Number
    3008021110-2023-00129
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    October 30, 2023
    Report Date
    February 15, 2024
    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 MANUFACTURING CHARTS OF INVOLVED LOT #2012511, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS MANUFACTURED WITH THAT LOT #. THIS IS THE FIRST AND ONLY COMPLAINT REPORTED ON THE INVOLVED LOT #. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2012511, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 35 DEVICES MANUFACTURED WITH THAT LOT #. ACCORDING TO OUR RECORDS, AT LEAST 33 OUT OF 35 HUMERAL STEMS WITH LOT #2012511 AND STER.2000361 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS: ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF THREE X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED - DATED (B)(6) 2023 - AND THREE PICTURES OF THE EXPLANTED DEVICES HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE HUMERAL COMPONENT LOOKS SLIGHTLY UNDERSIZED ON THE AP-RADIOGRAPHS, THE FINS DO NOT ENGAGE THE CORTEX. THERE IS NO BONE ON THE EXPLANT, WHICH REINFORCES THE THEORY THAT THIS COULD HAVE BEEN A PROBLEM. THE GLENOID COMPONENT IS LOOSE AND BROKEN OUT. THERE MAYBE A SURGICAL ERROR COMPONENT IN THIS, BUT THIS IS A BIT SPECULATIVE. I CANNOT SEE ANY IMPLANT-RELATED ISSUE HERE". BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION COULD HAVE BEEN PERFORMED. CONSIDERING THAT: CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH LOT #2012511; · ACCORDING TO THE MEDICAL CONSULTANT "THE HUMERAL COMPONENT LOOKS SLIGHTLY UNDERSIZED ON THE AP-RADIOGRAPHS, THE FINS DO NOT ENGAGE THE CORTEX" AND "THERE MAYBE A SURGICAL ERROR COMPONENT IN THIS, BUT THIS IS A BIT SPECULATIVE. I CANNOT SEE ANY IMPLANT-RELATED ISSUE HERE"; WE ARE NOT ABLE TO DRAW A DEFINITIVE ROOT-CAUSE FOR THE EVENT, STILL WE CAN STATE THAT IT WASN'T PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO LOOSENING OF THE HUMERAL SIDE IS 0.02%. 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 IMPLANT PERFORMED ON (B)(6) 2023, DUE TO IMPLANT LOOSENING. THE HUMERAL COMPONENT WAS LOOSE. THE GLENOID SIDE WAS REMOVED AS WELL: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.160, LOT #2012511 - STER. 2000361). SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #2020854 - STER. 2100029) - PRODUCT NOT SOLD IN THE US. SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #1903717 - STER. 1900158) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2017363 - STER. 2000315). SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2020679 - STER.2000345) - PRODUCT NOT SOLD IN THE US. SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2012380 - STER.2000253) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2006394 - STER.2000204). BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2018914 - STER.2000355). IT WAS REPORTED THAT THE PATIENT NEVER FELT COMFORTABLE OR HAPPY AFTER PRIMARY SURGERY, WHICH TOOK PLACE ON (B)(6) 2021. PATIENT IS A FEMALE, 82 YEARS OLD. NO COMORBIDITIES REPORTED. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2023, DUE TO IMPLANT LOOSENING. THE HUMERAL COMPONENT WAS LOOSE, THE GLENOID SIDE WAS REMOVED AS WELL: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.160, LOT #2012511 - STER. 2000361). SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #2020854 - STER. 2100029) - PRODUCT NOT SOLD IN THE US. · SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #1903717 - STER. 1900158) - PRODUCT NOT SOLD IN THE US. · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2017363 - STER. 2000315). · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2020679 - STER.2000345) - PRODUCT NOT SOLD IN THE US. · SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2012380 - STER.2000253) - PRODUCT NOT SOLD IN THE US. · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2006394 - STER.2000204). · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2018914 - STER.2000355). IT WAS REPORTED THAT THE PATIENT NEVER FELT COMFORTABLE OR HAPPY AFTER PRIMARY SURGERY, WHICH TOOK PLACE ON (B)(6) 2021. PATIENT IS A FEMALE, 82 YEARS OLD. NO COMORBIDITIES REPORTED. NO FURTHER CLINICAL INFORMATION AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620696 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM HSD LIMACORPORATE S.P.A. 1304.15.160 2012511

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention