BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 16-1101 CUSTOM HUMERAL STEM

    MDR report key: 16396603 · Received February 17, 2023

    Report

    Report Number
    3008021110-2023-00007
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    October 24, 2018
    Report Date
    March 15, 2024
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    JDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING CHARTS OF THE CMD 16-1101 CUSTOM HUMERAL STEM INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. 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 AVAILABLE. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT; THE MANUFACTURING CHARTS OF THE CMD 16-1101 CUSTOM HUMERAL STEM INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. ACCORDING TO THE FOLLOW-UP NOTES RECEIVED BY THE COMPLAINT SOURCE, IN SEPTEMBER 2018 THE X-RAYS SHOWED RADIOLUCENCY CIRCUMFERENTIALLY AROUND THE HUMERUS AND FAILURE OF INGROWTH. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA THE EVENT REPORTED BY THE COMPLAINT SOURCE IS LOOSENING OF A CUSTOM-MADE HUMERAL STEM. NO REVISION RATE CAN BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. NO CORRECTIVE ACTIONS ARE PLANNED FOR THIS CASE. LIMACORPORATE KEEPS MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE THIS IS THE FINAL DMR.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING CHARTS OF THE CMD 16-1101 CUSTOM HUMERAL STEM INVOLVED WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, DUE TO LOOSENING. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2016. DURING THIS SURGERY THE PROMADE CMD 16-1101, COMPOSED BY CUSTOM HUMERAL STEM (PRODUCT CODE 9617.99.013, LOT NUMBER 1615792, STERILIZATION NUMBER 1600332) AND CUSTOM ULNAR IMPLANT (PRODUCT CODE 9617.99.014, LOT NUMBER 1615793, STERILIZATION NUMBER 1600332), WAS IMPLANTED UNCEMENTED. ACCORDING TO THE FOLLOW-UP NOTES RECEIVED BY THE COMPLAINT SOURCE, IN SEPTEMBER 2018 THE X-RAYS SHOWED RADIOLUCENCY CIRCUMFERENTIALLY AROUND THE HUMERUS AND FAILURE OF INGROWTH. THUS, THE SURGEON DECIDED TO REVISE THE HUMERUS TO A CEMENTED COMPONENT. DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2018, NO COMPONENTS WERE EXPLANTED; THE AIM OF THIS SURGERY WAS ONLY TO CEMENT THE CMD 16-1101 CUSTOM HUMERAL STEM. THE PATIENT WILL UNDERGO A SECOND REVISION SURGERY, DUE TO LOOSENING AS BEFORE. THIS LOOSENING IS REGISTERED WITH THE INTERNAL COMPLAINT # (B)(4) AND REPORTED WITH MFR 3008021110-2023-00008. PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1984 EVENT HAPPENED IN US.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2018, DUE TO LOOSENING. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2016. DURING THIS SURGERY THE PROMADE CMD 16-1101, COMPOSED BY CUSTOM HUMERAL STEM (PRODUCT CODE 9617.99.013, LOT NUMBER 1615792, STERILIZATION NUMBER (B)(4)) AND CUSTOM ULNAR IMPLANT (PRODUCT CODE 9617.99.014, LOT NUMBER 1615793, STERILIZATION NUMBER (B)(4)), WAS IMPLANTED UNCEMENTED. ACCORDING TO THE FOLLOW-UP NOTES RECEIVED BY THE COMPLAINT SOURCE, IN (B)(6) 2018 THE X-RAYS SHOWED RADIOLUCENCY CIRCUMFERENTIALLY AROUND THE HUMERUS AND FAILURE OF INGROWTH. THUS, THE SURGEON DECIDED TO REVISE THE HUMERUS TO A CEMENTED COMPONENT. DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2018, NO COMPONENTS WERE EXPLANTED; THE AIM OF THIS SURGERY WAS ONLY TO CEMENT THE CMD 16-1101 CUSTOM HUMERAL STEM. THE PATIENT WILL UNDERGO A SECOND REVISION SURGERY, DUE TO LOOSENING AS BEFORE. THIS LOOSENING IS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH MFR 3008021110-2023-00008. PATIENT IS A FEMALE, 39 YEARS OLD. EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110295 CMD 16-1101 CUSTOM HUMERAL STEM CMD 16-1101 CUSTOM HUMERAL STEM - CUSTOM MADE JDB LIMACORPORATE S.P.A 9617.99.013 1615792

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention