BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRESERVE STEM 6MM

    MDR report key: 18650663 · Received February 6, 2024

    Report

    Report Number
    1038671-2024-00156
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 15, 2024
    Report Date
    September 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    PMA / PMN Number
    K162726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING DEVICE RETURN AND INVESTIGATION. D10: A686739 320-08-38 - GLENOSPHERE EXP 38MM +4MM OFFSET. A803831 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. A553317 320-15-04 - RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT A604339 320-15-05 - EQ REV LOCKING SCREW . A790789 320-15-05 - EQ REV LOCKING SCREW . A832830 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT S348719 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM . S396718 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. S457230 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM . S498332 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM . S495447 320-38-00 - 145-DEG PE 38MM HUM LINER +0.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF HUMERAL LOOSENING AND DISLOCATION. THE REPORTED HUMERAL LOOSENING AND DISLOCATION COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. 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

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT DISLOCATED AND WAS REVISED ON (B)(6) 2024, WHERE THE STEM CAME OUT BY HAND. 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. THIS IS THE SECOND PATIENT TO HAVE A SIZE 6 PRESERVE STEM LOOSE WITHIN THE FIRST FEW WEEKS OF THE ORIGINAL SURGERY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA. THE PATIENT DISLOCATED AND WAS REVISED, WHERE THE STEM CAME OUT BY HAND. 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. THIS IS THE SECOND PATIENT TO HAVE A SIZE 6 PRESERVE STEM LOOSE WITHIN THE FIRST FEW WEEKS OF THE ORIGINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541795 EQUINOXE PRESERVE STEM 6MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10.