BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P BONE CEMENT

    MDR report key: 3972995 · Received July 29, 2014

    Report

    Report Number
    MW5037538
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    April 15, 2014
    Report Date
    July 29, 2014
    Manufacturer
    STRYKER
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT ON (B)(6) 2009. SEVERAL MONTHS AGO MY KNEE BEGAN TO ACHE, EXPERIENCING TIGHTNESS, OCCASIONAL CRUNCHING SENSATION, AND PAIN BEHIND THE KNEE. I BELIEVE THIS DEVICE IS ALSO CAUSING THE PAIN TO RADIATE TO MY FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441545 SIMPLEX P BONE CEMENT BONE CEMENT LOD STRYKER SIMPLEX P BONE RLP236
    441546 SIGMA ROTATING PLATFORM KNEE SIGMA ROTATING PLATFORM KNEE JWH DEPUY OVAL DOME PATELLA 3-PEG 35MM 2820389

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR