BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    UNKNOWN AEQUALIS ASCEND FLEX COCR REVERSE FRACTURE HUMERAL STEM

    MDR report key: 14569326 · Received June 1, 2022

    Report

    Report Number
    3000931034-2022-00236
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    March 11, 2022
    Report Date
    July 13, 2022
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF EVENTS SUMMARIZED AS PART OF LITERATURE REVIEW, WHEN DEVICE AND PATIENT INFORMATION IS NOT AVAILABLE. THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED FRACTURE, WHICH REQUIRED REVISION SURGERY, COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE REFER TO H1 SUMMARY REPORT & H1 NUMBER OF EVENTS SUMMARIZED. PLEASE NOTE THE H1 SUMMARY REPORT TAB AND H1 NUMBER OF EVENTS SUMMARIZED TAB WERE SELECTED IN ERROR.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF NATIONAL REGISTRY RELEASED BY THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY. THE REPORT PROVIDES INFORMATION ON THE USAGE AND OUTCOMES OF THE AEQUALIS REVERSED II SHOULDER SYSTEM. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 876 PATIENTS, THE CASES IN THIS STUDY RANGE FROM 16 APRIL 2004 AND 9 MARCH 2022. THIS REPORT WAS GENERATED ON (B)(6) 2022. DURING THE REVIEW OF THE REGISTRY, IT WAS NOT POSSIBLE TO ESTABLISH SPECIFIC DEVICE DETAILS, PATIENT INFORMATION, AND NO ADDITIONAL DEVICE INFORMATION WILL BE MADE AVAILABLE. IT WAS REPORTED THAT 4 PATIENTS EXPERIENCED FRACTURE, WHICH REQUIRED REVISION SURGERY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF NATIONAL REGISTRY RELEASED BY THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY. THE REPORT PROVIDES INFORMATION ON THE USAGE AND OUTCOMES OF THE AEQUALIS REVERSED II SHOULDER SYSTEM. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 876 PATIENTS, THE CASES IN THIS STUDY RANGE FROM 16 APRIL 2004 AND 9 MARCH 2022. THIS REPORT WAS GENERATED ON MARCH 11, 2022. DURING THE REVIEW OF THE REGISTRY, IT WAS NOT POSSIBLE TO ESTABLISH SPECIFIC DEVICE DETAILS, PATIENT INFORMATION, AND NO ADDITIONAL DEVICE INFORMATION WILL BE MADE AVAILABLE. IT WAS REPORTED THAT 4 PATIENTS EXPERIENCED FRACTURE, WHICH REQUIRED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335050 UNKNOWN AEQUALIS ASCEND FLEX COCR REVERSE FRACTURE HUMERAL STEM PROSTHESIS SHOULDER JOINT METAL/POLYMER KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention