BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHORT TIBIA BEARING COMPONENT

    MDR report key: 603343 · Received May 16, 2005

    Report

    Report Number
    9610726-2005-00021
    Event Type
    Injury
    Date Received
    May 16, 2005
    Date of Event
    March 22, 2005
    Report Date
    April 1, 2005
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "A BROKEN MRS PROXIMAL TIBIA/KRH FEMUR PRESENTED TO THE SURGEON WITH NO OPERATIVE REPORT. THE ORIGINAL SURGERY WAS DONE WITH NO OTHER INFORMATION. THE PATIENT HAD FRACTURED THE TIBIAL BEARING COMPONENT FOR THE SECOND TIME." PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHORT TIBIA BEARING COMPONENT IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA GOXKD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention