BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 21260752 · Received January 28, 2025

    Report

    Report Number
    1038671-2025-00512
    Event Type
    Injury
    Date Received
    January 28, 2025
    Report Date
    April 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5 - MDR #S REFERENCED CORRECTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B5.

    Additional Manufacturer Narrative · 0

    H6: THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    1038671-2025-00515. 1038671-2025-00513. 1038671-2025-00514.

    Description of Event or Problem · 0

    OTHER INCIDENTS REPORTED UNDER MDR#S 31- 1038671-2025-00515. 29-1038671-2025-00513. 30-1038671-2025-00514.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT STATED THAT SINCE 2004, THEY HAVE HAD FIVE SHOULDER REPLACEMENTS, NONE OF WHICH ACHIEVED THE DESIRED RESULTS, SOME RESULTING IN THE SCREW BACKING OUT. NO OTHER INFORMATION KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818850 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention