BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVO MOTION REVERSE

    MDR report key: 21114765 · Received January 9, 2025

    Report

    Report Number
    3007319107-2025-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 18, 2024
    Report Date
    April 15, 2025
    Manufacturer
    ARTHROSURFACE
    Product Code
    PHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION AT THE MANUFACTURING PLANT. RETRACTION: THE INITIAL MDR SUBMISSION HAS THE INCORRECT MFR REPORT NUMBER WHICH IS INCORRECTLY LISTED AS 3007319107. A NEW SUBMISSION WITH THE CORRECT BUSINESS REGISTRATION NUMBER 3004154314 WILL BE SUBMITTED INCLUDING THE INVESTIGATON BY THE MANUFACTURING PLANT.

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION AT THE MANUFACTURING PLANT.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON (B)(6) 2024 IT WAS REPORTED THAT THE 36MM 2 CONCENTRIC GLENOSPHERE SEPERATED FROM THE 23MM BASEPLATE ON A PATIENT OF UNKNOWN AGE AND DEMOGRAPHIC. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE DATE OF THE DIAGNOSIS IS UNKNOWN. ADDIONAL INFORMATION WAS SOLICITED. THIS WILL BE ONE OF TWO SUBMISSIONS FOR THE SAME EVENT.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 18DECEMBER2024 IT WAS REPORTED THAT THE 36MM 2 CONCENTRIC GLENOSPHERE SEPERATED FROM THE 23MM BASEPLATE ON A PATIENT OF UNKNOWN AGE AND DEMOGRAPHIC. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE DATE OF THE DIAGNOSIS IS UNKNOWN. ADDIONAL INFORMATION WAS SOLICITED. THIS WILL BE ONE OF TWO SUBMISSIONS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365390 OVO MOTION REVERSE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHROSURFACE 75CC8581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention