BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TS FEMUR WITHOUT LFIT

    MDR report key: 2121434 · Received June 7, 2011

    Report

    Report Number
    2249697-2011-00829
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K994128
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND 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, "THE PT HAD A TKA ON (B)(6). HE DISLOCATED HIS PATELLA (NOT REPLACED) ON (B)(6). THEREFORE, THE SURGEON WILL PERFORM ADDITIONALLY TO REPLACE IT ON (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO TS FEMUR WITHOUT LFIT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MHL7TA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention