BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    MDR report key: 18903039 · Received March 14, 2024

    Report

    Report Number
    3000931034-2024-00106
    Event Type
    Injury
    Date Received
    March 14, 2024
    Date of Event
    February 22, 2023
    Report Date
    May 14, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME 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 FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. 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. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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

    IT WAS REPORTED THAT A PATIENT HAD REVISION SURGERY DUE TO INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD REVISION SURGERY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456155 AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. 2127AV

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention