BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4221794 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04137
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    January 1, 2002
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER UPDATED INFORMATION RECEIVED FROM SALES REPRESENTATIVE, THE PATIENT HAD 2 STRYKER REVISIONS. REVISION REPORTED UNDER THIS PI WAS FOR A PFC TOTAL KNEE, NO STRYKER DEVICES WERE INVOLVED.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN SCORPIO TS INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT THE CUSTOMER ALLEGEDLY REVISED A COMPETITOR'S DEVICE IN 2002 AND IMPLANTED A SCORPIO TS AT THAT TIME. THIS DEVICE WAS EXPLANTED ON (B)(6) 2005, FOR UNKNOWN REASONS.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT THE CUSTOMER ALLEGEDLY REVISED A COMPETITOR'S DEVICE IN 2002 AND IMPLANTED A SCORPIO TS AT THAT TIME. THIS DEVICE WAS EXPLANTED ON (B)(6) 2005, FOR UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703812 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R