BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9034124 · Received September 13, 2019

    Report

    Report Number
    1038671-2019-00449
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    May 29, 2019
    Report Date
    November 4, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862201027
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (G5) PMA/510(K)NUMBER: K113309. (H3) DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THERE IS NO INDICATION THAT THERE IS A DEVICE RELATED PROBLEM, THERE IS NO ALLEGATION AGAINST THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED EVENT, INSTABILITY/SUBLUXATION, IS RELATED TO THE UNDERLYING PATIENT CONDITIONS.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: EQUINOXE PRESERVE STEM 12MM (CN# 300-30-12); EQUINOXE, HUMERAL HEAD EXPANDED, 50MM (BETA) (CN# 310-03-50); EQUINOXE REPLICATOR PLATE 4.5MM O/S (CN# 300-10-45).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT RECEIVED A RIGHT SHOULDER ARTHROPLASTY ON (B)(6) 2019. PATIENT WAS THEN REVISED DUE TO INSTABILITY/SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825940 EQUINOXE CAGE GLENOID L, POST AUG, RIGHT KWT EXACTECH, INC. 10885862201027

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.