BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER STANDARD 6

    MDR report key: 4240330 · Received October 30, 2014

    Report

    Report Number
    1651501-2014-00050
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K130050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PT, SAME INCIDENT, DIFFERENT PRODUCT IDS). THIS REPORT IS IN REGARDS TO THE LINER STANDARD 6. THE PT HAD A REVERSE TOTAL SHOULDER ON (B)(6) 2014. THE PT RETURNED TO SEE THE PHYSICIAN ON (B)(6) 2014 AS HE HAD PROBLEMS AFTER PUSHING OFF/UP FROM A TABLE. X-RAYS SHOWED THAT THE GLENOSPHERE HAD DISASSOCIATED. ON (B)(6) 2014, REVISION SURGERY WAS PERFORMED TO REPLACE THE GLENOSPHERE. DURING THE OPERATION, IT WAS DISCOVERED THAT THE POLY HAD BEEN DAMAGED. BOTH COMPONENTS WERE REPLACED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695213 LINER STANDARD 6 TITAN SHOULDER SYSTEM KWS ASCENSION ORTHOPEDICS 13-1994

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention GLENOSPHERE ECC 5MM