BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER SIMPLICITI NUCLEUS SIZE 2

    MDR report key: 16898018 · Received May 9, 2023

    Report

    Report Number
    0001649390-2023-00079
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    September 4, 2014
    Report Date
    June 9, 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

    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.

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE, PART #DWG402, IS COMMERCIALLY AVAILABLE CLEARED 510K K143552. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    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    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2014 A PATIENT REQUIRED REVISION SURGERY DUE "ASEPTIC LOOSENING", WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : "SINGLE STAGE REVISION¿.

    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 (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 04 SEPTEMBER 2014 A PATIENT REQUIRED REVISION SURGERY DUE "ASEPTIC LOOSENING", WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : "SINGLE STAGE REVISION¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688510 TORNIER SIMPLICITI NUCLEUS SIZE 2 PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL PKC TORNIER INC CC0811194

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention