BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL STD

    MDR report key: 14841080 · Received June 28, 2022

    Report

    Report Number
    3008021110-2022-00056
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    March 19, 2022
    Report Date
    June 28, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS PROCESSED WITH THOSE STERILIZATION #S. THEREFORE, ALL THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S/STER. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: PATHOGEN RESPONSIBLE FOR THE INFECTION AND RESULTS OF SPECIMEN ANALYSIS; PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; CLINICAL DATA FOR THE PATIENT. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED BY STER. #2100119 AND #2200015, 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 0.069%. 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 COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2022, DUE TO WOUND INFECTION. THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. THE FOLLOWING IMPLANTS WERE REMOVED AND REPLACED: SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2104963 - STER. 2100119); SMR REVERSE HP GLENOSPERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2127160 - STER. 2200015). PRODUCT NOT MARKETED IN THE US. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A MALE (B)(6). NO PATIENT CLINICAL HISTORY IS AVAILABLE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029578 SMR CONNECTOR SMALL STD CONNECTOR WITH SCREW SMALL-STD KWS LIMACORPORATE S.P.A. 1374.15.310 2104963

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other