BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    MDR report key: 16781863 · Received April 20, 2023

    Report

    Report Number
    3000931034-2023-00107
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 22, 2023
    Report Date
    June 5, 2023
    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

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE CLEARED 510K K081059. H3 OTHER TEXT : DEVICE WAS DISCARDED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. ONLY A PHOTO OF THE EXPLANTED PARTS TAKEN DURING REVISION SURGERY WAS PROVIDED WITH NO OTHER DATA FOR INVESTIGATION. SINCE DATA WERE PROVIDED, THE OPINION OF A MEDICAL EXPERT WAS SOUGHT AND STATED AS FOLLOWING: "WITH THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO CONFIRM THE EVENT OF INFECTION 100% SURE, WITHOUT RESULTS FROM X-RAYS, TISSUE CULTURES, ETC. WE CAN BE SURE THE SURGEON EXPLANTED FOUR PARTS OF THE RTSA, BUT WE¿LL NEED MORE INFORMATION TO CONFIRM THE DIAGNOSIS AND LOOK IN TO FACTORS THAT MAY HAVE PLAYED A ROLE". MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICES MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOTS DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT REVERSE SHOULDER REPLACEMENT, IN 2017. RECENTLY THE PATIENT HAD DISCHARGING SINUS, OVER PROSTHETIC JOINT. SURGEON DECIDED TO REMOVE ANY LOOSE PROSTHESIS. MULTIPLE SEROUS AND TISSUE SPECIMENS TAKEN FROM RIGHT PROSTHETIC SHOULDER JOINT. HUMERAL COMPONENT, THOUGH VERY WELL FIXED, WAS REMOVED. GLENOSPHERE REMOVED - SPECIMENS TAKEN OF "JELLY-LIKE" MATERIAL BEHIND THE GLENOSPHERE. GLENOID BASEPLATE LEFT INSITU, AS VERY WELL FIXED. COPIOUS LAVAGE. ANTIBIOTIC LADEN CEMENT SPACER PLACED IN JOINT SPACE, AND WOUND CLOSED. THE SURGEON PRESCRIBED THE PATIENT 2 WEEKS OF IV ANTIBIOTICS. THE PATIENT WILL THEN UNDERGO A 2ND STAGE REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT REVERSE SHOULDER REPLACEMENT, IN 2017. RECENTLY THE PATIENT HAD DISCHARGING SINUS, OVER PROSTHETIC JOINT. SURGEON DECIDED TO REMOVE ANY LOOSE PROSTHESIS. MULTIPLE SEROUS AND TISSUE SPECIMENS TAKEN FROM RIGHT PROSTHETIC SHOULDER JOINT. HUMERAL COMPONENT, THOUGH VERY WELL FIXED, WAS REMOVED. GLENOSPHERE REMOVED - SPECIMENS TAKEN OF "JELLY-LIKE" MATERIAL BEHIND THE GLENOSPHERE. GLENOID BASEPLATE LEFT INSITU, AS VERY WELL FIXED. COPIOUS LAVAGE. ANTIBIOTIC LADEN CEMENT SPACER PLACED IN JOINT SPACE, AND WOUND CLOSED. THE SURGEON PRESCRIBED THE PATIENT 2 WEEKS OF IV ANTIBIOTICS. THE PATIENT WILL THEN UNDERGO A 2ND STAGE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547625 AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. 7062AS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention