BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT SCORPIO KNEE REPLACEMENT SYSTEM

    MDR report key: 2922543 · Received January 15, 2013

    Report

    Report Number
    2249697-2013-90143
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    February 23, 2005
    Report Date
    December 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A LEGAL REP THAT ALLEGEDLY, THE PT UNDERWENT BILATERAL SIMULTANEOUS TOTAL KNEE REPLACEMENTS. IT IS ALLEGED THAT, SOMETIME DURING 2009, THE PT BEGAN EXPERIENCING SIGNIFICANT PAIN IN HER KNEES, WITH HER RIGHT KNEE BEING MORE PAINFUL THAN THE LEFT. ON OR ABOUT (B)(6) 2012, AN X-RAY WAS PERFORMED ON HER RIGHT KNEE. THE DOCTOR INFORMED HER THAT THE SCORPIO IMPLANT WAS LOOSE AND THAT IT NEEDED TO BE REPLACED. ON (B)(6) 2012, THE PATIENT UNDERWENT A REVISION RIGHT KNEE ARTHROPLASTY OF THE ENTIRE FEMORAL AND TIBIAL COMPONENTS. OPERATIVE FINDINGS REVEALED A GROSSLY LOOSE TIBIAL COMPONENT WITH DEBONDING OF THE CEMENT FROM THE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22209 UNKNOWN RIGHT SCORPIO KNEE REPLACEMENT SYSTEM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R