BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL STD

    MDR report key: 13964355 · Received March 31, 2022

    Report

    Report Number
    3008021110-2022-00023
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    March 23, 2022
    Report Date
    August 28, 2022
    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

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO ANOMALIES WERE FOUND ON THE ITEMS MANUFACTURED WITH THESE LOT #S. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED - ONE DATED (B)(6) 2019 AND THE OTHER DATED (B)(6) 2022 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE PRE-REVISION RADIOGRAPHS SHOW CLEAR EVIDENCE OF INFECTION AS SUSPECTED BY THE SOURCE WITH OSTEOLYSIS AT THE HUMERAL METAPHYSIS AS WELL AT THE GLENOID. THIS IS THEREFORE A FATEFUL EVENT AND NOT IMPLANT-RELATED". CONSIDERING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT # - STER.; · ACCORDING TO THE MEDICAL CONSULTANT "THE PRE-REVISION RADIOGRAPHS SHOW CLEAR EVIDENCE OF INFECTION [...]. THIS IS THEREFORE A FATEFUL EVENT AND NOT IMPLANT-RELATED"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION IS 0.068%. 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 REPORT.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO INFECTION. THE FOLLOWING ITEMS WERE EXPLANTED: SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1362.09.015, LOT #1811420 - STER. 1800291) - PRODUCT NOT MARKETED IN THE US. SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #1904625 - STER. 1900108). SMR REVERSE HP CORRECTIVE GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT #1906250 - STER. 1900230) - PRODUCT NOT MARKETED IN THE US. SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #1211758 - STER. 1200331) - PRODUCT NOT MARKETED IN THE US. BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #1212117 - STER. 1200320). BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #1211133 - STER. 1200317). ACCORDING TO THE COMPLAINT SOURCE, SPECIMEN WAS TAKEN, HOWEVER THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. IT WAS REPORTED THAT THE ORIGINAL PLAN WAS TO WASHOUT AND EXCHANGE THE GLENOSPHERE AND THE LINER. HOWEVER, DUE TO AN INTRA-OPERATIVE ISSUE, THE WHOLE GLENOID HAD TO BE REMOVED. THE INTRA-OPERATIVE ISSUE WAS REGISTERED AS COMPLAINT #(B)(4). THE PROSTHESIS WAS CONVERTED TO HEMI. PATIENT'S CLINICAL HISTORY OF SHOULDER SURGERIES IS THE FOLLOWING: PRIMARY SURGERY TOOK PLACE ON (B)(6) 2013. A SMR ANATOMIC TOTAL WAS IMPLANTED; FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, DUE TO CUFF FAILURE (NO FURTHER DETAILS AVAILABLE); SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2022, AND IT WAS DUE TO INFECTION (HEREBY REPORTED). PATIENT IS A MALE, (B)(6). EVENT HAPPENED IN (B)(6).

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON MARCH 23RD, 2022, DUE TO INFECTION. THE FOLLOWING ITEMS WERE EXPLANTED: · SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1362.09.015, LOT #1811420 - STER. 1800291) - PRODUCT NOT MARKETED IN THE US · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #1904625 - STER. 1900108) · SMR REVERSE HP CORRECTIVE GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT #1906250 - STER. 1900230) - PRODUCT NOT MARKETED IN THE US · SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #1211758 - STER. 1200331) - PRODUCT NOT MARKETED IN THE US · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #1212117 - STER. 1200320) · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #1211133 - STER. 1200317) ACCORDING TO THE COMPLAINT SOURCE, SPECIMEN WAS TAKEN, HOWEVER THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. IT WAS REPORTED THAT THE ORIGINAL PLAN WAS TO WASHOUT AND EXCHANGE THE GLENOSPHERE AND THE LINER. HOWEVER, DUE TO AN INTRA-OPERATIVE ISSUE, THE WHOLE GLENOID HAD TO BE REMOVED. THE INTRA-OPERATIVE ISSUE WAS REGISTERED AS COMPLAINT # (B)(4) AND REPORTED TO THE FDA BY MFR 3008021110-2022-00026. THE PROSTHESIS WAS CONVERTED TO HEMI. PATIENT'S CLINICAL HISTORY OF SHOULDER SURGERIES IS THE FOLLOWING: - PRIMARY SURGERY TOOK PLACE ON (B)(6) 2013. A SMR ANATOMIC TOTAL WAS IMPLANTED; - FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, DUE TO CUFF FAILURE (NO FURTHER DETAILS AVAILABLE); - SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2022, AND IT WAS DUE TO INFECTION (HEREBY REPORTED). PATIENT IS A MALE, 72 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842682 SMR CONNECTOR SMALL STD CONNECTOR WITH SCREW SMALL-STD KWS LIMACORPORATE S.P.A. 1374.15.310 1904625

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention