BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE COMPONENT

    MDR report key: 20654024 · Received November 11, 2024

    Report

    Report Number
    1038671-2024-04334
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862563712
    PMA / PMN Number
    K193098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.CORRECTED FIELDS: A2(DELETE D.O.B.), B2, B3, D1, D4(DELETE ALL), G4(DELETE DATE), H4 (DELETE DATE), G6-MEDICAL DEVICE PROBLEM CODE.

    Additional Manufacturer Narrative · 0

    (D10) REPORTED CONCOMITANT DEVICE(S): 300-30-08 - EQUINOXE PRESERVE STEM 8MM: A193229, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: A071443, 320-15-01 - EQ REV GLENOID PLATE: A213855, 320-42-00 - 145-DEG PE 42MM HUM LINER +0: A199997.

    Description of Event or Problem · 0

    APPROXIMATELY 1 YEAR(S), 8 MONTH(S) AND 5 DAY(S) POST-OPERATIVE OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING WITH SHOULDER PAIN AND INFECTION. APPROXIMATELY 3 MONTHS FOLLOWING THE ONSET OF SYMPTOMS, THE PATIENT RECEIVED A STEROID INJECTION AND ASPIRATION. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING, AND THE CLINICAL REPORT INDICATES THAT THE EVENT IS POSSIBLY RELATED TO THE DEVICE(S) 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
    972297 EQUINOXE COMPONENT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862563712

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other| R SEE H11.