BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8955171 · Received September 3, 2019

    Report

    Report Number
    1038671-2019-00444
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    August 22, 2019
    Report Date
    October 28, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079398
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (B2) ADDED HOSPITALIZATION - INITIAL OR PROLONGED CHECK BOX. (G5) PMA/510(K)NUMBER: K042021 (H3) 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 CAUSE OF THE REVISION DUE TO PAIN IS MOST LIKELY IS RELATED TO AN UNDERLYING CONDITION OF THE PATIENT. (H4) 28-JAN-2010.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE(S): TORQUE DEFINING SCREW KIT (CAT# 300-20-02 / SN# (B)(4)). HUMERAL HEAD SHORT 44MM (CAT# 310-01-44 / SN# (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. THE ORIGINAL TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED ON THIS FEMALE PATIENT¿S RIGHT SHOULDER ON (B)(6) 2010. THE GLENOID COMPONENT HAD BEEN PREVIOUSLY REMOVED, AND THE PATIENT HAD A HEMI SHOULDER LEFT IN, SO THE PHYSICIAN WANTED TO REVISE TO AN RSA. THE PHYSICIAN EXPOSED THE HUMERAL COMPONENT, REMOVED THE HUMERAL HEAD AND REPLICATOR PLATE AND CHECKED STABILITY OF STEM. IT WAS WELL FIXED. HE THEN PROCEEDED TO THE GLENOID WHERE HE TOOK CULTURES, THEN IMPLANTED AN 8 DEGREE POSTERIOR BASEPLATE. HE FIXATED THE BASEPLATE WITH PERIPHERAL SCREWS AND TRIALED A 38MM GLENOSPHERE WITH A +0 TRAY AND +0 LINER FOR A 38MM GLENOSPHERE. ROM CHECKED AND DETERMINED THOSE TO BE THE CORRECT SIZES. THE PHYSICIAN THEN IMPLANTED A 38MM GLENOSPHERE WITH A +0MM HUMERAL TRAY AND +0MM POLY FOR A 38MM GLENOSPHERE. IT WAS ASSEMBLED IN SITU AND STABILITY WAS CHECKED AND DEEMED APPROPRIATE. THE PATIENT WAS STABLE AT THE END OF THE CASE AND IS EXPECTED TO HAVE A GOOD OUTCOME. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749292 EQUINOXE EQUINOXE REPLICATOR PLATE 4.5MM O/S KWT EXACTECH, INC. 10885862079398

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R