BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIOFLEX TOTAL KNEE PS

    MDR report key: 2171345 · Received July 18, 2011

    Report

    Report Number
    9616680-2011-00483
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K041591
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING REVISION, IT WAS FOUND THAT A POST WAS BROKEN OFF OF THE POLY ON A SCORPIO PS KNEE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIOFLEX TOTAL KNEE PS IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention