BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9890658 · Received March 27, 2020

    Report

    Report Number
    1038671-2020-00265
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    June 29, 2016
    Report Date
    April 14, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER: 314-02-04, SERIAL NUMBER: (B)(4), EXPIRATION DATE: 10-DEC-2009, UNIQUE IDENTIFIER (UDI) #: (B)(4). CONCOMITANT DEVICE(S): 310-01-44, 1045870, EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA) PMA/510(K)NUMBER: K042021. THE ASEPTIC (NON-INFECTED) GLENOID LOOSENING REPORTED MAY HAVE BE THE RESULT OF A DETERIORATION OF THE BOND BETWEEN THE BONE AND IMPLANT THAT CONTINUES TO PROGRESS AND LEAD TO PAIN AS THE DEVICES ARE STILL IMPLANTED. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. DEVICE MANUFACTURE DATE: 13-DEC-2004.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED, (B)(6) Y/O FEMALE, WHO IS APPROXIMATELY 13 YEARS POSTOP, HAS BEEN EXPERIENCING PROGRESSIVE GLENOID LOOSENING WITH INCREASED PAIN OVER SINCE LATE 2019. PATIENT HAS HISTORY OF RHEUMATOID ARTHRITIS. SUBJECT IS TOO FRAIL FOR REVISION. THE PATIENT WILL CONTINUE TO BE FOLLOWED BY THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355295 EQUINOXE GLENOID KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R