BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE GLENOID, PEGGED ALPHA, MEDIUM

    MDR report key: 21859165 · Received April 17, 2025

    Report

    Report Number
    1038671-2025-01850
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 26, 2025
    Report Date
    July 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862084484
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS: 7236081 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S, A090374 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT, A137783 300-30-07 - EQUINOXE PRESERVE STEM 7MM, 7014366 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA). H3: 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 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 ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, E, G. THE REVISION REPORTED MAY BE THE RESULT OF THE GLENOID FRACTURE LEADING TO MIGRATION AS REPORTED. THE REPORTED LOSS OF RANGE OF MOTION WAS LIKELY DUE TO THE REPORTED DISPLACED IMPLANT AS THE HUMERAL HEAD ARTICULATES ON THE GLENOID IMPLANT COMPONENT. THE GLENOID WAS REPORTED TO BE FRACTURED BUT RADIOGRAPHS AND IMAGES WERE NOT AVAILABLE. CONTRIBUTING FACTORS TO THE REPORTED FRACTURE MAY INCLUDE A COMBINATION OF ARTICULAR SURFACE WEAR AND THINNING OF THE GLENOID BODY, INCOMPLETE SEATING, AND/OR ECCENTRIC LOADING AROUND A WELL-FIXED CENTER CAGE WITH LOOSENING OF THE PERIPHERAL PEGS MAY HAVE LED TO THE FRACTURE BUT THIS CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED. POTENTIAL CONTRIBUTIONS OF PATIENT AND USER-RELATED ISSUES TO THE EVENT CANNOT BE DETERMINED FROM THE REPORTED 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

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED 2 YEAR 2 MONTHS POST INITIAL OPERATION. THE CENTRAL PEG BROKE FROM IMPLANT AND IMPLANT WAS DISPLACED IN SHOULDER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733116 EQUINOXE GLENOID, PEGGED ALPHA, MEDIUM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 10885862084484

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Hospitalization