BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    MDR report key: 15292877 · Received August 25, 2022

    Report

    Report Number
    1038671-2022-00965
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    July 28, 2022
    Report Date
    April 22, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862172693
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 310-01-47 EQUINOXE, HUMERAL HEAD SHORT, 47MM (BETA) K042021, 300-10-15 EQUINOXE REPLICATOR PLATE 1.5MM O/S K042021, 300-20-02 EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT K042021, DEVICE EVALUATED BY MFR: NO DEVICE RETURNING DUE TO HOSPITAL POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, 62 YO, WHO HAD AN INITIAL RIGHT SHOULDER IMPLANT PROCEDURE ON (B)(6) 2018, HAD A ROTATOR CUFF THAT DETERIORATED OVER TIME. THE SURGEON ELECTED TO CONVERT HER TO A RTSA APPROXIMATELY 4 YEARS 2 MONTHS POST THE INITIAL IMPLANT PROCEDURE TO IMPROVE STABILITY AND ROM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES ARE RETURNING DUE TO HOSPITAL POLICY. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF SURGICAL REVISION FOR ROTATOR CUFF DETERIORATION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420069 EQUINOXE PRIMARY SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, BETA UNK 10885862172693

    Patients

    Seq Age Sex Outcome Treatment
    1