BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY ACETABULAR SYSTEM

    MDR report key: 4951566 · Received July 28, 2015

    Report

    Report Number
    9614209-2015-00035
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    June 18, 2015
    Report Date
    January 19, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    OQI
    PMA / PMN Number
    K111481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DETAILS, PATIENT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS WILL BE REVIEWED.

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL REPORT. THE DEVICES WERE REVISED DUE TO PAIN AND THE INITIAL REPORTER STATED THAT THIS WAS DUE TO PELVIC TILT RESULTING IN EDGE LOADING. THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE DEVICES WERE MANUFACTURED TO MATERIAL AND DIMENSIONAL SPECIFICATION.

    Description of Event or Problem · 1

    REVISION OF TRINITY SHELL, LINER AND HEAD AFTER 2 YEARS DUE TO PAIN AND PELVIC TILT.

    Description of Event or Problem · 1

    REVISION OF TRINITY SHELL, LINER AND HEAD AFTER 2 YEARS DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488619 TRINITY ACETABULAR SYSTEM ACETABULAR SHELL OQI CORIN MEDICAL 321.02.350 252951

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ASSOCIATED CERAMIC MODULAR HEAD 104.3205,| LOT 195795