BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSCORPIO TS TIB INSERT

    MDR report key: 1971487 · Received January 20, 2011

    Report

    Report Number
    9616680-2011-00028
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K994128
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT PRESENTED WITH AN INFECTED TOTAL KNEE ARTHROPLASTY. THE POLY INSERT WAS REMOVED AND AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED. THE INSERT WAS REPLACED WITH ONE SIZE THICKER FOR STABILITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NSCORPIO TS TIB INSERT IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA 29100101

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention