BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12933364 · Received December 6, 2021

    Report

    Report Number
    1038671-2021-00660
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    November 16, 2021
    Report Date
    May 19, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862196163
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER? PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE(S): 310-01-44, 6744741 - EQ HUMERAL HEAD SHORT 44MM ALPHA, 300-51-45, 6141041 - 4.5MM SHORT FA REP PLT KIT.

    Additional Manufacturer Narrative · 0

    (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INSTABILITY AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 MONTHS POSTOP THE INITIAL R TSA THIS (B)(6) Y/O FEMALE PATIENT HAD EARLY INSTABILITY FOLLOWING A ANATOMIC SHOULDER. SHE HAD AN ANTEVERTED GLENOID AND AN AUGMENT WAS USED TO CORRECT THIS ORIGINALLY. DECISION WAS MADE TO CONVERT TO A REVERSE. UPON REVISION SUBSCAP WAS SOLID AND ALL COMPONENTS APPEARED SOLIDLY FIXED. STEM WAS RETAINED. REASON FOR INSTABILITY IS UNKNOWN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. FACILITY POLICY DOE NOT ALLOW DEVICES TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830119 EQUINOXE CAGE GLENOID S, POST AUG, LEFT KWT EXACTECH, INC. 314-13-22 UNK 10885862196163

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| R