BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 17233675 · Received June 29, 2023

    Report

    Report Number
    1038671-2023-01510
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    October 1, 2023
    Report Date
    July 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: 320-36-00 REVERSE HUMERAL LINER 320-10-05 REVERSE HUMERAL TRAY 320-36-00 HUMERAL LINER +0 UNCONSTRAINED 36MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, D4, D6B, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE CAUSE OF THE PATIENT¿S REPORTED INFECTION LEADING TO SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. 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

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 76 YO FEMALE PATIENT EXPERIENCED AN ANTERIOR DISLOCATION CAUSED BY DEEP JOINT INFECTION. THERE WAS NO INJURY MOI REPORTED. THE DATE OF EVENT ONSET IS (B)(6) 2023. THE PATIENT WAS REVISED ON (B)(6) 2023. ADDITIONAL PATIENT TREATMENT INVOLVED, RTSA HARDWARE REMOVAL AND PLACEMENT OF ANTIBIOTIC SPACER. THE OUTCOME WAS LAST KNOWN AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865328 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other| R SEE H10