BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER SIMPLICITI NUCLEUS SIZE 3

    MDR report key: 18048165 · Received November 1, 2023

    Report

    Report Number
    0001649390-2023-00296
    Event Type
    Injury
    Date Received
    November 1, 2023
    Date of Event
    July 1, 2015
    Report Date
    November 1, 2023
    Manufacturer
    TORNIER INC
    Product Code
    PKC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE WAS CLEARED UNDER 510K # K143552 WAS CLEARED IN THE UNITED STATES. 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 WAS NOT NECESSARY BECAUSE THE IMPLANT AFFECTED BY THIS COMPLAINT HAS BEEN MANUFACTURED PRIOR TO 2018. AS A RESULT, THIS IMPLANT IS EXPIRED AND CAN NO LONGER BE PUT ON THE MARKET OR IMPLANTED. THE COMPLAINT HISTORY REVIEW FOUND NO OTHER COMPLAINT RECORDED FOR THIS LOT NUMBER. MOREOVER, THE POST MARKET SURVEILLANCE REVIEWS HAVE NOT IDENTIFIED ANY SIGNALS FOR SIMILAR ISSUES THAT WOULD HAVE CHALLENGED THE EFFICACY AND SAFETY OF THIS PRODUCT. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. THE NATURE OF THE COMPLAINT DOESN¿T NECESSITATE A DRAWING REVIEW. 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.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2015 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091877 TORNIER SIMPLICITI NUCLEUS SIZE 3 PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM PKC TORNIER INC AZ0112365

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention