BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL STD

    MDR report key: 16732882 · Received April 13, 2023

    Report

    Report Number
    3008021110-2023-00039
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    April 5, 2023
    Report Date
    July 5, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    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 OVERALL NUMBER. ALL THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. DEVICE ANALYSIS THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS LIMACORPORATE RECEIVED A TOTAL OF THREE X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED - DATED 26/03/2023 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THIS IS ALL DUE TO INFECTION, THERE ARE NO IMPLANT-RELATED PROBLEMS TO BE OBSERVED". CONSIDERING THAT: CHECK OF STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED WITH THE INVOLVED LOT #S; ACCORDING TO THE MEDICAL CONSULTANT THE REVISION SURGERY IS DUE TO INFECTION AND THERE ARE NO IMPLANT-RELATED PROBLEMS; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS 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 CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS STERILIZED WITH THOSE LOT #S. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6), 2023, DUE TO INFECTION. THE FOLLOWING COMPONENTS GOT EXPLANTED AND REPLACED: SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #2219918 - STER. 2200267) - PRODUCT NOT SOLD IN THE US SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2226283 - STER. 2200318) SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2300434 - STER. 2300013) - PRODUCT NOT SOLD IN THE US IT WAS REPORTED THAT A WASHOUT WAS PERFORMED, AND SPECIMEN WERE TAKEN, HOWEVER THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2023. PATIENT IS A FEMALE. NO OTHER CLINICAL INFORMATION IS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO INFECTION. THE FOLLOWING COMPONENTS GOT EXPLANTED AND REPLACED: · SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #2219918 - STER. 2200267) - PRODUCT NOT SOLD IN THE US; · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2226283 - STER. 2200318); · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2300434 - STER. 2300013) - PRODUCT NOT SOLD IN THE US; IT WAS REPORTED THAT A WASHOUT WAS PERFORMED, AND SPECIMEN WERE TAKEN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. PATIENT IS A FEMALE. NO OTHER CLINICAL INFORMATION IS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027344 SMR CONNECTOR SMALL STD CONNECTOR WITH SCREW SMALL-STD PHX LIMACORPORATE S.P.A. 1374.15.310 2226283
    1254610 SMR CONNECTOR SMALL STD CONNECTOR WITH SCREW SMALL-STD PHX LIMACORPORATE S.P.A. 1374.15.310 2226283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention