BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI TS BASEPLATE SIZE 6

    MDR report key: 1150525 · Received September 5, 2008

    Report

    Report Number
    9610726-2008-00057
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    K053514
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFORMATION A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SURGEON STATED TIBIA HAD LOOSENED, REVISED TIBIAL TRAY AND INSERT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI TS BASEPLATE SIZE 6 IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA UTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention