BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID S, POST AUG, LEFT

    MDR report key: 19218176 · Received April 30, 2024

    Report

    Report Number
    1038671-2024-01020
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    May 1, 2023
    Report Date
    February 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862196163
    PMA / PMN Number
    K113309
    Removal / Correction Number
    Z-1414-2024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-62-01 - STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 1 : 6450475. 310-62-47 - STEMLESS HUMERAL HEAD 47MM X 15MM X BETA : 6160237. 315-35-00 - GLND KWIRE : 6980330. 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM : 6981150. (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3/G4, H6. THE FOLLOWING SECTIONS WERE 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 AN INSUFFICIENT BOND BETWEEN THE GLENOID COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) GLENOID LOOSENING. 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 BY THE EQUINOXE SHOULDER STUDY, THE 64-YEAR-OLD WHITE FEMALE HAD A LEFT TSA ON (B)(6) 2021. THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING ON (B)(6) 2023. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION SURGERY ON (B)(6) 2024 IN WHICH THE PATIENT WAS REVISED TO EXACTECH HYBRID RTSA AND THE OUTCOME IS CONSIDERED RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130712 EQUINOXE CAGE GLENOID S, POST AUG, LEFT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862196163

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female SEE H10