BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM

    MDR report key: 20175941 · Received September 9, 2024

    Report

    Report Number
    1038671-2024-03387
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 20, 2024
    Report Date
    December 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862079312
    PMA / PMN Number
    K042021
    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 FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 THE FOLLOWING SECTIONS WERE CORRECTED: B2 D6B D8 H6. THE REVISION REPORTED WAS LIKELY THE RESULT OF HUMERAL LOOSENING POSSIBLY LEADING TO STEM MIGRATION AND JOINT DISLOCATION. HOWEVER, THIS CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS FROM PATIENT OR USER RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION, AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS 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

    PENDING INVESTIGATION. D10: A966201 - 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE. A998298- 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. A744140- 320-15-01 - EQ REV GLENOID PLATE. A960792 -320-15-05 - EQ REV LOCKING SCREW. A950920 -320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. A824269- 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. A693600- 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. A784432- 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S505139- 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. A969263 -320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0 A886348- 531-78-20 - SHOULDR GPS HEX PINS KIT. 11054823170- A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 MONTHS POST AN INITIAL RIGHT TSA, THE STEM ROTATED INSIDE THE CANAL AND THE PATIENT DISLOCATED THEIR SHOULDER. THE PATIENT WAS REVISED AND EVERYTHING WAS REMOVED. THE SURGEON DECIDED TO CEMENT IN A STEM AND DO A HIGHER GLENOSPHERE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329936 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 10885862079312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R