BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO PS FEMUR WAFFLE POSTS W/LFIT

    MDR report key: 1193509 · Received October 8, 2008

    Report

    Report Number
    2249697-2008-00306
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    December 19, 2007
    Report Date
    August 28, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN DOCUMENTED AS PART OF A CLINICAL STUDY. DEVICE NOT RETURNED. DEVICE IS STILL IMPLANTED IN PT AND THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. SHOULD DEVICE BECOME AVAILABLE WITH ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CASE REPORT FORM AS A COMPLICATION FOR SCORPIO+PS MBK IDE STUDY. EVENT DESCRIBED AS "PES ANSERINUS BURSITIS." CIRCUMSTANCES SURROUNDING ONSET OF COMPLICATION DESCRIBED AS "ANTERIOR KNEE PAIN." EVENT REPORTED AS UNCERTAIN REGARDING RELATION TO DEVICE, AND MODERATE IN SEVERITY. TREATED WITH PHYSICAL THERAPY ON (B)(6) 2008, AND UNRESOLVED AS OF (B)(6) 2008.

    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 N9AMTA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other