BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOSPHERE Ø 36MM

    MDR report key: 15457444 · Received September 20, 2022

    Report

    Report Number
    3008021110-2022-00085
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    September 15, 2022
    Report Date
    January 17, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K163397
    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 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. THEREFORE, ALL 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 - DATED 01/09/2022 - AND A COUPLE OF PICTURES OF THE EXPLANTED ITEMS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THERE IS OBVIOUS INFECTION; THE GLENOID EXPLANT SHOWS SUSPICIOUS TISSUE FOR INFECTION AT THE GLENOID SIDE. THE RADIOGRAPH OTHERWISE LOOKS UNREMARKABLE; THE EXPLANTS OTHERWISE ARE UNREMARKABLE. THERE IS NO IMPLANT-RELATED PROBLEM HERE. THIS IS INFECTION AS THE REASON FOR REVISION, A FATEFUL COURSE OF EVENTS". CONSIDERING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S - STER; · THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN; · ACCORDING TO THE MEDICAL CONSULTANT "THERE IS OBVIOUS INFECTION; THE GLENOID EXPLANT SHOWS SUSPICIOUS TISSUE FOR INFECTION AT THE GLENOID SIDE. THE RADIOGRAPH OTHERWISE LOOKS UNREMARKABLE"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION IS 0.075%. 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 EXPLANTED AND REPLACED: SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT #19AT31H - STER. 1900453) - PRODUCT NOT SOLD IN THE US, SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #1912815 - STER. 1900325), SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2103804 - STER. 2100093), SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2101474 - STER. 2100078) - PRODUCT NOT SOLD IN THE US, BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2101695 - STER. 2100068), BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #2020452 - STER. 2000401), IT WAS REPORTED THAT SPECIMEN WAS TAKEN DURING SURGERY, HOWEVER THE RESULTS ARE NOT AVAILABLE AND THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A FEMALE. EVENT HAPPENED IN AUSTRALIA.

    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 EXPLANTED AND REPLACED: · SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT #19AT31H - STER. 1900453) - PRODUCT NOT SOLD IN THE US · SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #1912815 - STER. 1900325) · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2103804 - STER. 2100093) · SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2101474 - STER. 2100078) - PRODUCT NOT SOLD IN THE US · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2101695 - STER. 2100068) · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #2020452 - STER. 2000401) IT WAS REPORTED THAT SPECIMEN WAS TAKEN DURING SURGERY, HOWEVER THE RESULTS ARE NOT AVAILABLE AND THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2021. PATIENT IS A FEMALE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698976 SMR GLENOSPHERE Ø 36MM GLENOSPHERE DIA. 36 MM KWS LIMACORPORATE S.P.A. 1374.09.111 1912815

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention