BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER SIMPLICITI NUCLEUS SIZE 1

    MDR report key: 19520010 · Received June 12, 2024

    Report

    Report Number
    0001649390-2024-00264
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    May 14, 2024
    Report Date
    August 23, 2024
    Manufacturer
    TORNIER INC
    Product Code
    PKC
    PMA / PMN Number
    K143552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MICROBIOLOGIST REVIEWED THE STERILIZATION PROCEDURES, ENVIRONMENTAL MONITORING, BIOBURDEN DATA AND THE DHR AND NOTED: THE SUBJECT DEVICE WAS PACKAGED ACCORDING TO ESTABLISHED DESIGN AND PROCESS SPECIFICATIONS, AND WAS STERILIZED ACCORDING TO PROCEDURE. NO DEVIATION FOR A NON-CONFORMANCE COULD BE FOUND. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INFECTIONS ARE OFTEN CAUSED BY A MULTITUDE OF FACTORS SUCH AS COMORBIDITY OF THE PATIENT, THE TRAUMA, THE SURGICAL INTERVENTION, AND THE AFTERCARE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (DWG401) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K143552. BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183378 TORNIER SIMPLICITI NUCLEUS SIZE 1 PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM PKC TORNIER INC CC0221307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention