BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS FEMUR WAFFLE W/LFIT

    MDR report key: 1770198 · Received July 21, 2010

    Report

    Report Number
    2249697-2010-00864
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 12, 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
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: SCORP MOB BPLATE SIZE 5 (IDE), CAT# 79-1005-CS; LOT 2993201. SCORPIO+IDE #05 10MM PS INSERT, CAT# 78-3-0510-CS; LOT 74898603. SCORPIO M-DOME PATELLA, CAT# 73-0510; LOT L635. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IN THE PT (AS OF (B)(6) 2009) AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. IF DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE FOLLOWING INFO WAS OBTAINED VIA A PHONE QUESTIONNAIRE. WHEN THE PT WAS ASKED "DO YOU HAVE ANY PAIN IN YOUR KNEE THAT HAS THE STUDY KNEE REPLACEMENT?" IT WAS NOTED BY THE PERSON CONDUCTING THE PHONE CALL, "MILD OCCASIONAL LATERAL KNEE PAIN." THE DATE THE INDIVIDUAL SPOKE TO THE PT VIA PHONE WAS USED AS THE EVENT DATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS FEMUR WAFFLE W/LFIT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA K02M714

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other