BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO CR TB INSERT

    MDR report key: 2912752 · Received January 7, 2013

    Report

    Report Number
    2249697-2013-90051
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K974556
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 7115-005, LOT# T04T1077, DESCRIPTION: SERIES 7000 STANDARD TIBIA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED FOR PAIN. PLAN WAS TO PERFORM ANALYSIS OF ADHESION, POLY EXCHANGE AND PATELLA RESURFACING. UPON INSPECTION OF THE IMPLANTS IT WAS DETERMINED THAT THE TIBIAL COMPONENT WAS LOOSE. ALL IMPLANT WERE REMOVED AND TRIATHLON TS IMPLANTS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8099 SCORPIO CR TB INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 18146401

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention