BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS MINI STEM

    MDR report key: 10162719 · Received June 17, 2020

    Report

    Report Number
    3008021110-2020-00046
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    January 20, 2020
    Report Date
    June 17, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHECK OF THE DHR: BY CHECKING THE DHR OF THE LOTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED ON: SMR CEMENTLESS MINI STEMS MANUFACTURED WITH LOT#1902168 - 1900116, SMR REVERSE HUMERAL BODY SHORT MANUFACTURED WITH LOT#1912272 - 1900318, SMR REVERSE HP LINERS SHORT MANUFACTURED WITH LOT#1907672 - 1900222, SMR CONNECTORS SMALL R MANUFACTURED WITH LOT#1911361 - 1900293, SMR REVERSE HP GLENOSPH. 40 MM MANUFACTURED WITH LOT#1915180 - 1900335, SMR UNCEMENT. GLENOID #SMALL-R MANUFACTURED WITH LOT#1910171 - 1900261. THEREFORE, WE CAN ENSURE THAT ALL THE COMPONENTS WERE CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO FURTHER COMPLAINTS DUE TO INFECTION RECEIVED ON THESE STERILIZATION NUMBERS. XRAYS ANALYSIS: WE RECEIVED PRE-FIRST STAGE REVISION XRAYS DATED (B)(6) 2020 AND SENT THEM TO OUR MEDICAL CONSULTANT FOR A CLINICAL INVESTIGATION. FOLLOWING, HIS OPINION IS REPORTED: "I ALWAYS LOOK AT THE UNDERSIDE OF THE ACROMION TO GET A CLUE AS TO THE PRIMARY DIAGNOSIS THAT LED TO THE INDEX PROCEDURE. IN THIS CASE THERE IS A SMALL OSTEOPHYTE UNDER THE TIP OF THE ACROMION BUT NOTHING THAT WOULD AMOUNT TO CUFF TEAR ARTHROPATHY. I THEREFORE ASSUME THE INDICATION FOR REVERSE WAS GLENOHUMERAL ARTHRITIS WITH ASSOCIATED SUPERIOR CUFF DAMAGE. THIS HAS NO BEARING ON THE OUTCOME OF THE INDEX PROCEDURE WHICH IS CLEARLY PROSTHETIC JOINT INFECTION. THE IMAGING SHOWS CLEAR EVIDENCE OF LYSIS AND LOOSENING OF THE STEM CONSISTENT WITH INFECTION. I CANNOT BE SURE ABOUT THE BASEPLATE AND PEG BECAUSE THE IMAGE PLANE IS SUBOPTIMAL FOR THAT ANALYSIS. WE HAVE NO INFORMATION RE COMORBIDITIES OR RISK FACTORS. WHILE A TWO STAGE PROCEDURE IS STILL ACCEPTED APPROPRIATE PRACTICE AND GIVEN THE SEVERITY OF THE BONEY DAMAGE I THINK IT IS THE RIGHT CHOICE IN THIS CASE, THERE IS GROWING EVIDENCE A "TWO STAGE SINGLE EVENT" PROCEDURE IS A BETTER ALTERNATIVE." ACCORDING TO THE OPINION OF OUR MEDICAL CONSULTANT, THERE ARE CLEAR SIGNS OF LOOSENING AND LYSIS DUE TO INFECTION. ON THE BASIS OF THE INFORMATION RECEIVED, WE ARE NOT ABLE TO INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THE ABSENCE OF SIMILAR COMPLAINTS ON THE SAME STERILIZATION NUMBERS AND THE FACT THAT THE CHECK OF THE DHRS DID NOT REVEAL ANY PRE-EXISTING ANOMALY, WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, REVISION RATE OF SMR REVERSE DUE TO INFECTION IS 0.059%. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET. PLEASE, CONSIDER THIS REPORT AS INITIAL-FINAL MDR.

    Description of Event or Problem · 1

    FIRST STAGE REVISION OF SMR REVERSE SYSTEM DUE TO INFECTION OCCURRED ON (B)(6) 2020. PRIMARY SURGERY WAS PERFORMED IN (B)(6) 2019. DURING 1ST STAGE REVISION, ALL THE FOLLOWING IMPLANTS WERE REMOVED AND REPLACED WITH A CEMENT SPACER WITH ANTIBIOTIC: SMR CEMENTLESS MINI STEM, PRODUCT CODE 1304.15.130, LOT#1902168 - 1900116, SMR REVERSE HUMERAL BODY SHORT, PRODUCT CODE 1352.15.005, LOT#1912272 - 1900318, SMR REVERSE HP LINER SHORT, NOT MARKED IN US, SMR CONNECTOR SMALL R, PRODUCT CODE 1374.15.305, LOT#1911361 - 1900293, SMR REVERSE HP GLENOSPH. 40 MM, NOT MARKED IN US, SMR UNCEMENT. GLENOID #SMALL-R, NOT MARKED IN US. SECOND STAGE REVISION WAS PERFORMED ON (B)(6) 2020; CEMENT SPACER WAS REMOVED AND A FULL SMR REVERSE WITH AXIOMA TT METAL BACK WAS IMPLANTED. NO FURTHER INFORMATION AVAILABLE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627204 SMR CEMENTLESS MINI STEM SMR CEMENTLESS MINI STEM (HSD-KWT) HSD LIMACORPORATE SPA 1304.15.130 1902168

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention