BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    MDR report key: 11373803 · Received February 24, 2021

    Report

    Report Number
    1038671-2021-00073
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    February 17, 2021
    Report Date
    September 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    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): 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: (B)(6). 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S: (B)(6). 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT: (B)(6). 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA): (B)(6). 314-02-03 - EQUINOXE GLENOID, PEGGED ALPHA, MEDIUM: (B)(6).

    Description of Event or Problem · 0

    APPROXIMATELY 10 YEAR(S), 9 MONTH(S) AND 27 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DEEP INFECTION. THE PATIENT HAD INCREASING PAIN WITHOUT MOI (MECHANISM OF INJURY). PREVIOUSLY BIOPSIED CULTURES SHOWED INFECTION. THIS WAS REPORTED ON 1038671-2021-00009. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION, AND THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS EVENT WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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 THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. CONCOMITANT MEDICAL DEVICE(S): STANDARD HUMERAL STEM. REPLICATOR PLATE. TORQUE SCREW. HUMERAL HEAD.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 11 YEARS POSTOP THE INITIAL L TSA IMPLANT, THIS (B)(6) Y/O FEMALE PRESENT WITH INCREASING PAIN WITHOUT MOI. A SCOPE BIOPSY WAS COMPLETED AND CULTURES TAKEN AND SHOWED DEEP INFECTION. A REVISION WAS COMPLETED ON THE L SHOULDER. DEVICES WILL NOT RETURN DUE TO CLINICAL STUDY POLICY. OUTCOME WAS NOTED AS "CONTINUING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271235 EQUINOXE PRIMARY SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R SEE H10.| SEE H11.