BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 10271051 · Received July 14, 2020

    Report

    Report Number
    3008021110-2020-00054
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    July 9, 2020
    Report Date
    April 19, 2021
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 47 OUT OF 70 CEMENTLESS FINNED STEMS WITH LOT#: 1906003 AND STER. 1900205 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT#. EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED TWO X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED (EXACT DATE UNKNOWN) HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE XRAY SHOWS MARKED LOOSENING OF THE HUMERAL STEM WITH PERIPROSTHETIC LYTIC SCALLOPING AROUND THE STEM AND CONSIDERABLE SUBSIDENCE. THE PROXIMAL DIAPHYSIS APPEARS TO BE SEPARATE FROM THE REST OF THE HUMERUS BUT THIS WOULD BE BETTER DETERMINED WITH A CT SCAN. THE IMAGES ARE BOTH "SCAPULAR AP" VIEWS, NOT JOINT SPACE SO IT IS DIFFICULT TO COMMENT ON THE GLENOID PROSTHESIS BUT THE SENSE I HAVE IS THAT THE GLENOID PROSTHESIS IS A "LITTLE HIGH" IN THE GLENOID AND THERE IS A SUGGESTION OF IMPINGEMENT PRESENT. THERE IS A SUGGESTION OF LYSIS AROUND THE LATERAL ASPECT OF THE SUPERIOR SCREW BUT THE PROJECTION IS OBLIQUE, SO IT IS NOT POSSIBLE TO MAKE DEFINITIVE COMMENTS ON THE GLENOID PROSTHESIS. MY ASSESSMENT OF THIS APPEARANCE IS THAT THIS PROSTHESIS IS INFECTED AND INDEED IT IS INFECTED UNTIL PROVEN OTHERWISE. WITHOUT OTHER DATA SUCH AS INFLAMMATORY MARKERS, TISSUE CULTURES AND HISTOLOGY I CANNOT BE MORE PRECISE. IN SUMMARY I THINK THIS IS PROSTHETIC JOINT INFECTION ." NO EVENTUAL INFECTION WAS CONFIRMED BY THE COMPLAINT SOURCE. IN CONCLUSION, WE CANNOT GO BACK TO CERTAINTY TO THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THE CHECK OF THE MANUFACTURING CHARTS OF THE INVOLVED LOT #S, AND THE OPINION OF THE MEDICAL EXPERT, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMA CORPORATE PMS DATA, WE CAN ESTIMATE A REVISION RATE OF CEMENTLESS FINNED STEMS WITH CODES 1304.15.XXX DUE TO LOOSENING TO BE VERY LOW (<0,01 %). NO SPECIFIC CORRECTIVE ACTIONS IMPLEMENTED IN RELATION TO THIS CASE. LIMA CORPORATE KEEPS MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY OF SMR REVERSE SYSTEM PERFORMED ON (B)(6) 2020 DUE TO STEM LOOSENING. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. ACCORDING TO THE INFORMATION PROVIDED, DURING REVISION SURGERY SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.140, LOT#: 1906003, STER.1900205) WAS EXPLANTED AND REPLACED WITH A 13 X 150MM REVISION STEM WITH A SHORT BODY WITH EXTENSIVE BONE GRAFTING, DUE TO THE NEED TO FILL IN THE VOID OF NON-UNION. IT WAS REPORTED THAT PATIENT WAS FEMALE, 78 YEARS OLD, VERY LIGHT AND FRAIL. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #1906003, NO PRE-EXISTING ANOMALY WAS DETECTED ON (B)(4) STEMS MANUFACTURED. THEREFORE, WE CAN STATE THAT ALL THE COMPONENTS WERE UP TO SPECIFICATIONS. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON (B)(6) 2020 OF SMR REVERSE SYSTEM DUE TO STEM LOOSENING. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. ACCORDING TO THE INFORMATION PROVIDED, DURING REVISION SURGERY SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT #1906003, STER.1900205) WAS EXPLANTED AND REPLACED WITH A 13 X 150 REVISION STEM WITH A SHORT BODY WITH EXTENSIVE BONE GRAFTING, DUE TO THE NEED TO FILL IN THE VOID OF NON-UNION. IT WAS REPORTED THAT PATIENT WAS FEMALE, (B)(6) YEARS OLD, VERY LIGHT AND FRAIL. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734808 SMR CEMENTLESS FINNED STEM SMR CEMENTLESS FINNED STEM (HSD-KWT) HSD LIMACORPORATE SPA 1304.15.140 1906003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention