BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQ REVSD CEMENTLESS HUMERAL METAPHYSIS DIA 36MM COATING HAP

    MDR report key: 19354134 · Received May 20, 2024

    Report

    Report Number
    3000931034-2024-00296
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    June 21, 2018
    Report Date
    May 20, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    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 (DWB960) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K030941. THE REPORTED EVENT OF A PATIENT REQUIRING REVISION SURGERY DUE TO INFECTION COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WILL BE MADE AVAILABLE BY THE NATIONAL JOINT REGISTRY. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE.   IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.   PLEASE NOTE, THAT REPORTS RECEIVED FROM THE NATIONAL JOINT REGISTRY ARE NOT PUBLISHED REPORTS AND THEREFORE WEB LINK IS 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    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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) MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 21-JUNE-2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609459 AEQ REVSD CEMENTLESS HUMERAL METAPHYSIS DIA 36MM COATING HAP PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. 6524AR

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention