BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY

    MDR report key: 15650550 · Received October 21, 2022

    Report

    Report Number
    3008021110-2022-00087
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    July 14, 2020
    Report Date
    August 9, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE STERILIZATION CHARTS OF THE INVOLVED DEVICES WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY ON THE 108 SMR HUMERAL EXTENSION + 9 MM THAT BELONG TO PRODUCT 1352.15.001, LOT 1919819, STERILIZATION 2000011. NO PRE-EXISTING ANOMALY ON THE 21 SMR REVERSE HUMERAL BODY THAT BELONG TO PRODUCT 1352.15.010, LOT 1921257, STERILIZATION 2000020. NO PRE-EXISTING ANOMALY ON THE 61 SMR REVERSE LINER + 3 MM THAT BELONG TO PRODUCT 1360.50.815, LOT 18AT0GL, STERILIZATION 1800099. NO PRE-EXISTING ANOMALY ON THE 35 SMR CEMENTLESS FINNED STEM THAT BELONG TO PRODUCT 1304.15.140, LOT 1801360, STERILIZATION 1800079. THEREFORE, WE CAN STATE THAT THE INVOLVED COMPONENTS WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL REPORT AFTER THE CONCLUSION OF THE INVESTIGATION. ACCORDING TO THE FDA COMMUNICATION RECEIVED ON OCTOBER 13TH 2022 BY EMAIL, THIS REPORT WAS DELAYED DUE TO THE ENROLLMENT PROCESS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION THE MANUFACTURING CHARTS OF THE INVOLVED DEVICES WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY ON THE 108 SMR HUMERAL EXTENSION + 9 MM BELONGING TO PRODUCT CODE: 1352.15.001, LOT: 1919819, STERILIZATION: 2000011. NO PRE-EXISTING ANOMALY ON THE 21 SMR REVERSE HUMERAL BODY BELONGING TO PRODUCT CODE: 1352.15.010, LOT: 1921257, STERILIZATION: 2000020. NO PRE-EXISTING ANOMALY ON THE 61 SMR REVERSE LINER + 3 MM BELONGING TO PRODUCT COD:E 1360.50.815, LOT: 18AT0GL, STERILIZATION: 1800099. NO PRE-EXISTING ANOMALY ON THE 35 SMR CEMENTLESS FINNED STEM BELONGING TO PRODUCT CODE: 1304.15.140, LOT: 1801360, STERILIZATION: 1800079. THEREFORE, WE CAN STATE THAT THE INVOLVED COMPONENTS HAVE FOLLOWED THE REGULAR PROCEDURES BEFORE BEING PLACED ON THE MARKET. ACCORDING TO OUR INFORMATION: AT LEAST (B)(4) OUT OF (B)(4) ITEMS BELONGING TO PRODUCT: 1352.15.001, LOT:: 1919819, STERILIZATION: 2000011 HAVE BEEN IMPLANTED. ALL THE (B)(4) ITEMS BELONGING TO PRODUCT: 1352.15.010, LOT: 1921257, STERILIZATION: 2000020 HAVE BEEN IMPLANTED. AT LEAST (B)(4) OUT OF (B)(4) ITEMS BELONGING TO PRODUCT CODE: 1360.50.815, LOT: 18AT0GL, STERILIZATION: 1800099 HAVE BEEN IMPLANTED. AT LEAST (B)(4) OUT OF (B)(4) ITEMS BELONGING TO PRODUCT CODE 1304.15.140, LOT 1801360, STERILIZATION: 1800079 HAVE BEEN IMPLANTED. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. EXPLANTS AND X-RAYS ANALYSIS: NO EXPLANT NOR X-RAYS WERE AVAILABLE TO BE ANALYSED, THEREFORE WE WERE NOT ABLE TO PERFORM ANY FURTHER INVESTIGATION. IN CONCLUSION, CONSIDERING THAT: NO PRE-EXISTING ANOMALY WAS FOUND BY CHECKING THE MANUFACTURING CHARTS OF THE PRODUCTS BELONGING TO THE LOT NUMBERS INVOLVED. NO FURTHER ANALYSIS CAN BE PERFORMED DUE TO THE UNAVAILABILITY OF THE EXPLANTS AND OF THE X-RAYS. WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THIS EVENT. NEVERTHELESS, WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE PMS DATA, THE REVISION RATE OF THE SMR REVERSE PROSTHESES DUE TO PAIN IS AROUND (B)(4). NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO BRUISING AND ARM PAIN. THE SURGEON OPENED THE SHOULDER AND PERFORMED AN AXILLARY NERVE NEUROLYSIS BECAUSE THE PATIENT EXHIBITED SOME DELTOID ATONY. CULTURES WERE TAKEN AND HELD FOR P ANCES. THE SURGEON THEN REMOVED THE LIMACORPORATE HUMERAL COMPONENT. THE WOUND WAS COPIOUSLY IRRIGATED WITH BACTISURE AND OTHER ANTIBIOTIC IRRIGANTS. DEVITALIZED TISSUE WAS EXCISED, AND DEEP CULTURES WERE TAKEN. COMPONENTS EXPLANTED: SMR HUMERAL EXTENSION + 9 MM (PRODUCT CODE 1352.15.001, LOT 1919819, STERILIZATION 2000011). SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.15.010, LOT 1921257, STERILIZATION 2000020). SMR REVERSE LINER + 3 MM (PRODUCT CODE 1360.50.815, LOT 18AT0GL, STERILIZATION 1800099). SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT 1801360, STERILIZATION 1800079). THE PATIENT WAS A FEMALE, 59 YEARS OLD. PATIENT'S SHOULDER CLINICAL HISTORY IS THE FOLLOWING: THE PRIMARY IMPLANT TOOK PLACE IN 2016 USING THIRD-PARTY COMPONENTS. THE IMPLANT USING COMPONENTS OF LIMACORPORATE WAS PERFORMED ON (B)(6) 2019. FIRST REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON (B)(6) 2019, DUE TO INFECTION, REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-00086 SECOND REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON FEBRUARY 21ST, 2020, DUE TO INFECTION, REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-00089. THIRD REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE (B)(6) 2020, DUE TO BRUISING AND ARM PAIN (HEREBY REPORTED). FOURTH REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON (B)(6) 2021, DUE TO PAIN AND LOSS OF RANGE OF MOTION, REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-00088. FIFTH REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON AUGUST 6TH, 2021, DUE TO PAIN, REGISTERED WITH THE INTERNAL COMPLAINT 243/22 AND REPORTED WITH THE MFR 3008021110-2022-00090. SIXTH REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON (B)(6) 2021, DUE TO BROKEN SCREW (NOT LIMACORPORATE) AND INFECTION, REGISTERED WITH THE INTERNAL COMPLAINT 244/22 AND REPORTED WITH THE MFR 3008021110-2022-00091.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO BRUISING AND ARM PAIN. THE SURGEON OPENED THE SHOULDER AND PERFORMED AN AXILLARY NERVE NEUROLYSIS BECAUSE THE PATIENT EXHIBITED SOME DELTOID ATONY. CULTURES WERE TAKEN AND HELD FOR PANCES. THE SURGEON THEN REMOVED THE LIMACORPORATE HUMERAL COMPONENT. THE WOUND WAS COPIOUSLY IRRIGATED WITH BACTISURE AND OTHER ANTIBIOTIC IRRIGANTS. DEVITALIZED TISSUE WAS EXCISED, AND DEEP CULTURES WERE TAKEN. COMPONENTS EXPLANTED: SMR HUMERAL EXTENSION + 9 MM (PRODUCT CODE: 1352.15.001, LOT: 1919819, STERILIZATION 2000011). SMR REVERSE HUMERAL BODY (PRODUCT CODE: 1352.15.010, LOT: 1921257, STERILIZATION 2000020). SMR REVERSE LINER + 3 MM (PRODUCT CODE: 1360.50.815, LOT: 18AT0GL, STERILIZATION 1800099). SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.140, LOT: 1801360, STERILIZATION 1800079). THE PATIENT WAS A FEMALE, 60 YEARS OLD. PATIENT'S SHOULDER CLINICAL HISTORY IS THE FOLLOWING: THE PRIMARY IMPLANT TOOK PLACE IN 2016 USING THIRD-PARTY COMPONENTS. THE IMPLANT USING COMPONENTS OF LIMACORPORATE WAS PERFORMED ON (B)(6) 2019. FIRST REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON (B)(6) 2019, DUE TO INFECTION, REGISTERED WITH THE INTERNAL COMPLAINT: (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-00086. SECOND REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON (B)(6) 2020, DUE TO INFECTION, REGISTERED WITH THE INTERNAL COMPLAINT: (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-00089. THIRD REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON (B)(4) 2020, DUE TO BRUISING AND ARM PAIN (HEREBY REPORTED). FOURTH REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON (B)(6) 2021, DUE TO PAIN AND LOSS OF RANGE OF MOTION, REGISTERED WITH THE INTERNAL COMPLAINT: (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-00088. FIFTH REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON (B)(6) DUE TO PAIN, REGISTERED WITH THE INTERNAL COMPLAINT: (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-00090. SIXTH REVISION SURGERY OF THE LIMA IMPLANT TOOK PLACE ON (B)(6) 2021, DUE TO BROKEN SCREW (NOT LIMACORPORATE) AND INFECTION, REGISTERED WITH THE INTERNAL COMPLAINT: (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-00091. AFTER THE SIXTH REVISION SURGERY, THE PATIENT UNDERWENT A CUSTOM-MADE IMPLANT SURGERY, BUT AFTER THE SURGERY THE CUSTOM IMPLANT WAS FOUND LOOSE, AND THE SEVENTH REVISION SURGERY WILL BE PERFORMED. EVENT HAPPENED IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647989 SMR REVERSE HUMERAL BODY SMR SHOULDER SYSTEM - REVERSE HUMERAL BODY FOR ELECTIVE SURGERY KWS LIMACORPORATE S.P.A. 1352.15.010 1921257

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention