BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRESERVE STEM 12MM

    MDR report key: 8649586 · Received May 29, 2019

    Report

    Report Number
    1038671-2019-00295
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 23, 2019
    Report Date
    October 16, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862515803
    PMA / PMN Number
    K162726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) EXPIRATION DATE: 12-AUG-2028 (E3) OCCUPATION: PHYSICIAN (E4) NO (G5) PMA/510(K)NUMBER: K162726 (H3) THE PATIENT REPORTED THAT INITIAL SURGERY TO THE RIGHT SHOULDER SURGERY IN 2018 DID NOT HEAL PROPERLY AND A LATER ARTHROSCOPIC SURGERY COULD NOT REPAIR IT AND IT BECAME INFECTED. SURGERY TO REMOVE THE METAL AND INSTALL AN ANTIBIOTIC SPACER WAS COMPLETED DUE TO THE INFECTION. AFTER THE INFECTION CLEARS, A REVERSE REPLACEMENT ON THE RIGHT SIDE WILL BE SCHEDULED. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. DEVICE SPECIFIC RISKS - FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROSTHESIS OR ANY OF ITS COMPONENTS, ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. INFECTION IS A KNOWN RISK IN ANY TOTAL JOINT SURGERY. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN, MANUFACTURING, OR PATIENT RELATED ISSUES. THE EVENT OF INFECTION IS GREATER THAN 3 MONTHS POSTOP AND IT IS HIGHLY UNLIKELY TO BE RELATED TO THE SURGICAL PROCEDURE OR DEVICES. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS RELATED TO THE UNDERLYING PATIENT CONDITION. THIS CANNOT BE DETERMINED AS DEVICES WERE NOT RETURNED FOR INVESTIGATION. (H4) 13-AUG-2018 NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A4, A5, B6, B7, D6, G8, H6, H7 SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (SECTION F) PLEASE DISREGARD F6 AND F8. THESE WERE ENTERED IN ERROR.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: EQUINOXE SQUARE TORQUE DEFINING SCREW DRIVE KIT (CN: 300-20-02; SN: (B)(4)); EQUINOXE REPLICATOR PLATE, 1.5MM O/S (CN: 300-10-15; SN: (B)(4)); EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT (CN: 314-13-35; SN: (B)(4)); EQUINOXE HUMERAL HEAD, SHORT, 53MM (BETA) (CN: 310-01-53; SN: (B)(4)).

    Description of Event or Problem · 1

    INDEX SURGERY: 2018. PATIENT'S RIGHT SHOULDER DID NOT HEAL PROPERLY, AND A LATER ARTHROSCOPIC SURGERY COULD NOT REPAIR IT AND IT BECAME INFECTED. PATIENT NEEDS SURGERY TO REMOVE THE METAL AND INSTALL AN ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445440 EQUINOXE PRESERVE STEM 12MM EQUINOXE PRESERVE STEM 12MM KWT EXACTECH, INC. EQUINOXE PRESERVE STEM 12MM 10885862515803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention