BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID SMALL, ALPHA

    MDR report key: 17439329 · Received August 1, 2023

    Report

    Report Number
    1038671-2023-01826
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    June 28, 2023
    Report Date
    May 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862172679
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 REPORTED GLENOID FAILURE MAY BE THE RESULT OF GLENOID LOOSENING AND FRACTURE OF THE CENTER PEG FROM THE POLYETHYLENE BODY. HOWEVER, THE FAILURE AND POTENTIAL CONTRIBUTIONS FROM MANUFACTURING, PATIENT, OR USER-RELATED ISSUES TO THE EVENT CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE 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: H4. 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

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3000109, HUMERAL HEAD 3100144, REPLICATOR PLATE 3001015.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 70 YO MALE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. THE X-RAY DEMONSTRATED LOOSE CAGE GLENOID POLY. THE DATE OF EVENT ONSET IS UNKNOWN. THE PATIENT WAS REVISED ON (B)(6) 2023. THE OUTCOME WAS LAST KNOWN AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796027 EQUINOXE CAGE GLENOID SMALL, ALPHA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. UNK UNK 10885862172679

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| O SEE H10.