BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER SIMPLICITI HUM HEADSIZE 5 8X18

    MDR report key: 20092156 · Received August 28, 2024

    Report

    Report Number
    0001649390-2024-00410
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    August 2, 2024
    Report Date
    November 18, 2024
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    UDI-DI
    00846832090457
    PMA / PMN Number
    K143552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT COMMUNICATED. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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

    ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN INFECTION CAUSED BY P. ACNES, AS IDENTIFIED BY THE BACTERIAL CULTURE. NO OTHER CONTRIBUTING FACTORS WERE REPORTED, AND THE IMPLANTS WERE DISCARDED AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN INFECTION CAUSED BY P. ACNES, AS IDENTIFIED BY THE BACTERIAL CULTURE. NO OTHER CONTRIBUTING FACTORS WERE REPORTED, AND THE IMPLANTS WERE DISCARDED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494925 TORNIER SIMPLICITI HUM HEADSIZE 5 8X18 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER INC UNKNOWN 00846832090457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention