BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS TIP INSERT

    MDR report key: 2121393 · Received June 7, 2011

    Report

    Report Number
    2249697-2011-00846
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD A POLY EXCHANGE FOR RIGHT KNEE PAIN THAT HAD BEEN WORSENING FOR SEVERAL YEARS. POLY WAS INCREASED IN THICKNESS FROM 8MM TO 10MM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS TIP INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 34968201

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention