BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQ REV GLENOID BASEPLATE 29MM

    MDR report key: 19367117 · Received May 21, 2024

    Report

    Report Number
    3000931034-2024-00309
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    July 15, 2016
    Report Date
    July 8, 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 (DWD002) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K050316. THE DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    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. MICROBIOLOGIST REVIEWED THE STERILIZATION PROCEDURES, ENVIRONMENTAL MONITORING, BIOBURDEN DATA AND THE DHR AND NOTED: THE SUBJECT DEVICE WAS PACKAGED ACCORDING TO ESTABLISHED DESIGN AND PROCESS SPECIFICATIONS, AND WAS STERILIZED ACCORDING TO PROCEDURE. NO DEVIATION FOR A NON-CONFORMANCE COULD BE FOUND. 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    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2016, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, 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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2016 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, 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
    1220812 AEQ REV GLENOID BASEPLATE 29MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. 9099AP

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention