BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL STD

    MDR report key: 10086188 · Received May 26, 2020

    Report

    Report Number
    3008021110-2020-00033
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    May 20, 2020
    Report Date
    May 26, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR PMS DATA, OCCURRENCE RATE OF INFECTION IN SMR REVERSE SYSTEM IS 0.061%. NONE OF THESE CASE WAS JUDGED AS PRODUCT RELATED. NO CORRECTIVE/PREVENTIVE ACTION IMPLEMENTED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL KEEP THE MARKET MONITORED. PLEASE, CONSIDER THIS REPORT AS AN INITIAL-FINAL MDR.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO EARLY INFECTION PERFORMED ON (B)(6) 2020. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. DURING REVISION SURGERY, WASH OUT WAS PERFORMED AND ONLY THE SMR REVERSE HP GLENOSPHERE (PRODUCT NOT MARKED IN USA), THE SMR REVERSE HP LINER (PRODUCT NOT MARKED IN USA) AND THE CONNECTOR (PRODUCT CODE 1374.15.310, LOT#1920252, STER. 2000003) WERE REPLACED. ACCORDING TO THE INFORMATION REPORTED, SURGEON SUSPECTED PATIENTS JOINT BECAME INFECTED ON THE WARD BECAUSE DRESSING WAS CHANGED TOO EARLY. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550588 SMR CONNECTOR SMALL STD SMR CONNECTOR SMALL STD KWS LIMACORPORATE SPA 1374.15.310 1920252

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention