BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TOTAL KNEE PS; TIBIAL BEARING INSERT

    MDR report key: 5759323 · Received June 29, 2016

    Report

    Report Number
    0002249697-2016-02084
    Event Type
    Injury
    Date Received
    June 29, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 1, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040964
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT THE LATER TIME IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    SCORPIO POSTERIOR STABILIZED TIBIAL INSERT (72-13-0912) INSERT POST BROKE, WHICH REQUIRED SURGERY TO REMOVE THE BROKEN INSERT POST AND PUT IN ANOTHER INSERT (SAME ITEM). SURGERY WAS ORIGINALLY DONE IN 2006, ACCORDING TO THE NURSE, BUT I DIDN'T SEE OFFICIAL OPERATIVE REPORT TO CONFIRM THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411660 SCORPIO TOTAL KNEE PS; TIBIAL BEARING INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention