BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED CEMENTLESS STEM HA D9MM L100MM

    MDR report key: 18842438 · Received March 5, 2024

    Report

    Report Number
    3000931034-2024-00085
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    October 7, 2018
    Report Date
    March 5, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE CLEARED 510K K030941. 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. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    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    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 07-OCTOBER-2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656433 AEQUALIS REVERSED CEMENTLESS STEM HA D9MM L100MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX TORNIER S.A.S. 2422AS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention