BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS FEMUR WAFFLE POSTS W/LFIT

    MDR report key: 1689143 · Received May 11, 2010

    Report

    Report Number
    2249697-2010-00514
    Event Type
    Injury
    Date Received
    May 11, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORDS, COMPLAINT HISTORY AND PACKAGING INSERT REVIEW. EVAL SUMMARY: AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS KEPT BY THE PT AND WAS NOT RETURNED TO THE MFR. THE REPORTED DEVICES, X-RAYS AND MEDICAL RECORDS WERE REQUESTED, BUT NOT MADE AVAILABLE. THE DEVICE MFG HISTORY RECORD FOR THE LOT CODE K01K568 INDICATES THAT DEVICES WERE MFG AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE PRODUCT EXPERIENCE REPORTING DATABASE SHOWS THAT THERE HAVE BEEN NO OTHER REPORTED EVENTS REGARDING THE REPORTED LOT CODE. A REVIEW OF THE PACKAGING INSERT NOTED THE FOLLOWING APPLICABLE WARNING: "LOOSENING OF TOTAL KNEE COMPONENTS CAN OCCUR. [...] LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS INCLUDING OSTEOLYSIS, OR MECHANICAL PROBLEMS, WITH THE SUBSEQUENT POSSIBILITY OF BONE EROSION AND/OR PAIN." IF DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 2249697-2010-00513.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "SCORPIO TOTAL KNEE COMPONENTS WERE EXPLANTED AND TRIATHLON TS WAS IMPLANTED. I DO NOT HAVE PERSONAL INFO ON PT BECAUSE OF CONFIDENTIALITY REGULATIONS." ADDITIONAL INFO RECEIVED STATED, "THIS KNEE WAS REVISED BECAUSE OF LOOSE COMPONENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS FEMUR WAFFLE POSTS W/LFIT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA K01K568

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention