BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL STD

    MDR report key: 15410905 · Received September 13, 2022

    Report

    Report Number
    3008021110-2022-00081
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    September 1, 2022
    Report Date
    December 16, 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 PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS STERILIZED WITH THE SAME LOT #S. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS STERILIZED WITH THE SAME LOT #S. 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 ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - DATE UNKNOWN - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THIS IS AN UNFORTUNATE CASE OF PERIPROSTHETIC INFECTION THAT LED TO THE REVISIONS AND MAY LEAD TO FURTHER REVISIONS IN THE FUTURE. THERE IS NO IMPLANT-RELATED ISSUE HERE". CONSIDERING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED WITH THE INVOLVED LOT #S; · ACCORDING TO THE RECEIVED INFORMATION, PATIENT HAS HAD INFECTION SINCE 2016, AND THE PATHOGEN WAS NOT COMPLETELY ERADICATED THROUGH THERAPY; · ACCORDING TO THE MEDICAL EXPERT'S OPINION "THIS IS AN UNFORTUNATE CASE OF PERIPROSTHETIC INFECTION"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR REVERSE DUE TO INFECTION IS 0.076%. 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 PROSTHESIS PERFORMED ON (B)(6), 2022, DUE TO INFECTION. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH ONES OF THE SAME SIZE: SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT #2121397 - STER. 2100350) - PRODUCT NOT MARKETED IN THE US. SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2126599 - STER. 2200030). SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2208715 - STER. 2200116). PRODUCT NOT MARKETED IN THE US. ACCORDING TO THE RECEIVED INFORMATION THE PATIENT HAS HAD INFECTION SINCE 2016. THE SAME PATHOGEN WAS NOT COMPLETELY ERADICATED THROUGH ANTIBIOTIC CEMENT AND ANTIBIOTIC IV. THE SAME ANATOMIC REGION WAS INVOLVED IN THE INFECTION. HOWEVER, THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. PATIENT IS A MALE. ACCORDING TO THE INFORMATION PROVIDED, THE SHOULDER REPLACEMENT THAT WAS REMOVED AND REPLACED WITH A CEMENT SPACER DUE TO INFECTION. NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. THE CEMENT SPACER WAS THEN REVISED BY USE OF LIMA COMPONENTS ON JULY 25TH, 2022. FOLLOWING THIS, THE PATIENT WAS STILL EXPERIENCING SIGNS OF INFECTION AND HENCE HE WAS REVISED ON (B)(6), 2022. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON SEPTEMBER 1ST, 2022, DUE TO INFECTION. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH ONES OF THE SAME SIZE: · SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT #2121397 - STER. 2100350) - PRODUCT NOT MARKETED IN THE US. · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2126599 - STER. 2200030). · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2208715 - STER. 2200116) - PRODUCT NOT MARKETED IN THE US. ACCORDING TO THE RECEIVED INFORMATION THE PATIENT HAS HAD INFECTION SINCE 2016. THE SAME PATHOGEN WAS NOT COMPLETELY ERADICATED THROUGH ANTIBIOTIC CEMENT AND ANTIBIOTIC IV. THE SAME ANATOMIC REGION WAS INVOLVED IN THE INFECTION. HOWEVER, THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. PATIENT IS A MALE; HE HAS A HIGH BMI AND PERFORMS MODERATE ACTIVITY LEVEL. ACCORDING TO THE INFORMATION PROVIDED, PATIENT HAD A SHOULDER REPLACEMENT (COMPETITOR'S PROSTHESIS) THAT WAS REMOVED AND REPLACED WITH A CEMENT SPACER DUE TO INFECTION. NO FURTHER INFORMATION IS AVAILABLE ON THAT EVENT. THE CEMENT SPACER WAS THEN REVISED ON JULY 25TH, 2022, AND LIMA COMPONENTS WERE IMPLANTED. FOLLOWING THIS, THE PATIENT WAS STILL EXPERIENCING SIGNS OF INFECTION AND HENCE HE WAS REVISED ON SEPTEMBER 1ST, 2022. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2391636 SMR CONNECTOR SMALL STD CONNECTOR WITH SCREW SMALL-STD KWS LIMACORPORATE S.P.A. 1374.15.310 2126599

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other