BEUDAMED
    FDA Adverse Event Other Summary report: N

    HRA COMPONENT SZ 44/18

    MDR report key: 3662540 · Received February 18, 2014

    Report

    Report Number
    1651501-2014-00011
    Event Type
    Other
    Date Received
    February 18, 2014
    Report Date
    January 28, 2014
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    HSD
    PMA / PMN Number
    K071064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT WHO PREVIOUSLY RECEIVED A TITAN HRA (METAL) IMPLANTED SUSTAINED A FALL AND RUPTURED THE ROTATOR CUFF. A REVISION SURGERY WAS PERFORMED AND A REVERSE SHOULDER SYSTEM WAS IMPLANTED. THE PT IS CURRENTLY ENROLLED IN A (B)(6). THE SURGEON DOES NOT FEEL THIS EVENT WAS RELATED TO THE TITAN HRA IMPLANT OR THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102942 HRA COMPONENT SZ 44/18 TITAN HRA HSD ASCENSION ORTHOPEDICS, INC. 11-2897

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention