BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS MINI STEM

    MDR report key: 11202442 · Received January 20, 2021

    Report

    Report Number
    3008021110-2021-00004
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    December 12, 2020
    Report Date
    May 25, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    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 STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. LIMACORPORATE RECEIVED ONE X-RAYS REFERRING TO POST-OP PREVIOUS SURGERY (DATED 03/12/2020), ONE X-RAYS REFERRING TO PRE-OP REVISION SURGERY (DATED (B)(6) 2020 ) AND ONE POST-OP REVISION SURGERY (DATED (B)(6) 2020 ). THE X-RAYS RECEIVED HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT, TAKING INTO CONSIDERATION BOTH COMPLAINTS #001_21 AND #008_21. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE PATIENT WITH SERIOUS CO-MORBIDITIES AND A DIAGNOSIS OF AVASCULAR NECROSIS HAD A REVERSE SHOULDER REPLACEMENT ON (B)(6) 2020 AND A REVISION FOR INFECTION JUST 9 DAYS LATER. UNDER THE GUIDELINES FOR MANAGEMENT FOR PJI THAT SOON AFTER THE PRIMARY SURGERY THE REVISION CARRIED OUT WITH A FURTHER REPLACEMENT IS JUSTIFIED ALTHOUGH INDIVIDUAL CIRCUMSTANCES MAY ADVISE AGAINST THAT. ON THE FIRST XRAY WE CAN SEE OLD PATHOLOGY RELATING TO THE A-C JOINT WHICH WAS PROBABLY TRAUMA RELATED. THIS IS NOT A CONTRAINDICATION TO REVERSE SHOULDER REPLACEMENT. THE PATIENT SUFFERED AVN. WE DO NOT HAVE IMMEDIATE PRE-OP XRAYS BEFORE THE INDEX PROCEDURE AND HAVE TO ASSUME THERE WERE INDICATIONS FOR REVERSE RATHER THAN THE USUAL HEMIARTHROPLASTY OR ANATOMICAL ARTHROPLASTY. WE HOPE SO BECAUSE PJI RISK IS SIGNIFICANTLY HIGHER IN REVERSE COMPARED WITH HEMI OR TOTAL ANATOMICAL REPLACEMENT. WE ASSUME THE PATIENT WAS CURED OF THEIR ALCOHOLISM. THERE IS A STRONG RELATIVE CONTRAINDICATION FOR ARTHROPLASTY IN PATIENTS WHO ARE STILL DRINKING. I THINK WITH THE EARLY RECURRENCE OF INFECTION FOLLOWING THE 1ST REVISION I WOULD NOT RECOMMEND FURTHER IMPLANTATION OTHER THAN A PROSTALAC PROSTHESIS, SO I BELIEVE THE 2ND REVISION WITH FURTHER IMPLANTATION IS A SERIOUS ERROR". BASED ON THE CHECK OF THE STERILIZATION CHARTS AND ACCORDING TO THE MEDICAL EXPERT'S OPINION, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE DUE TO INFECTION IS 0,06%. 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 SYSTEM PERFORMED ON DECEMBER 12TH, 2020 DUE TO SUSPECTED INFECTION. A WASHOUT WAS PLANNED, HOWEVER DURING IT, IT WAS NOTED THAT THE FEMORAL STEM PREVIOUSLY IMPLANTED WAS LOOSE. THE FOLLOWING IMPLANTS WERE REMOVED: · SMR CEMENTLESS MINI STEM (PRODUCT CODE 1304.15.120, LOT# 1920682 - STER. 1900455) · SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT# 2009767 - STER. 2000216) · SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT# 2011642 - STER. 2000273) - PRODUCT NOT MARKETED IN THE US. A CEMENTED REVISION STEM, A FINNED HUMERAL BODY AND A LATERALIZING LINER LONG WERE IMPLANTED. THE IMPLANT WAS REVISED ON JANUARY 5TH, 2021 FOR SUSPECTED INFECTION. THE REVISION SURGERY WAS REGISTERED AS LIMACORPORATE COMPLAINT #001_21 AND IT WAS REPORTED TO THE FDA AS MFR REPORT #3008021110-2021-00001. PRIMARY SURGERY TOOK PLACE ON DECEMBER 3RD, 2020. PATIENT IS A FEMALE, 44 YEARS OLD. IT WAS REPORTED THAT SHE HAS SUBSTANCE ABUSE PROBLEMS WITH ETOHIC CIRRHOSIS. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SEND A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    WE BECAME AWARE OF A REVISION SURGERY OF A SHOULDER SMR REVERSE SYSTEM PERFORMED ON (B)(6) 2020 DUE TO SUSPECTED INFECTION. A WASHOUT WAS PLANNED, HOWEVER DURING IT, IT WAS NOTED THAT THE STEM WAS LOOSE. THE FOLLOWING IMPLANTS WERE REMOVED: SMR CEMENTLESS MINI STEM (PRODUCT CODE 1304.15.120, LOT# 1920682 - STER. 1900455) SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE (B)(4), LOT# 2009767 - STER. 2000216). SMR REVERSE HP LINER SHORT (PRODUCT CODE (B)(4), LOT# 2011642 - STER. 2000273) - PRODUCT NOT MARKETED IN THE US. A CEMENTED REVISION STEM, A FINNED HUMERAL BODY AND A LATERALIZING LINER LONG WERE IMPLANTED. THE IMPLANT WAS REVISED ON (B)(6) 2021 FOR SUSPECTED INFECTION. THE REVISION SURGERY WAS REGISTERED AS COMPLAINT #001_21 LIMACORPORATE AND IT WAS REPORTED TO THE FDA (MFR REPORT #3008021110-2021-00001). PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97424 SMR CEMENTLESS MINI STEM FINNED HUMERAL STEMS - 60MM (TI6AL4V) DIA.12MM HSD LIMACORPORATE S.P.A. 1304.15.120 1920682

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention