BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT SCORPIO KNEE REPLACEMENT SYSTEM

    MDR report key: 2922542 · Received January 15, 2013

    Report

    Report Number
    2249697-2013-90144
    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, FOLLOWING THE REVISION RIGHT KNEE ARTHROPLASTY, IT WAS DISCOVERED THAT THE SCORPIO IMPLANT IN HER LEFT KNEE WAS ALSO LOOSE. IT IS FURTHER ALLEGED THAT, ON OR ABOUT (B)(6) 2012, SHE UNDERWENT A REVISION LEFT KNEE ARTHROPLASTY OF THE ENTIRE FEMORAL AND TIBIAL COMPONENT. OPERATIVE FINDINGS REVEALED A GROSSLY LOOSE TIBIAL COMPONENT THAT HAD DEBONDED FROM THE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22675 UNKNOWN LEFT SCORPIO KNEE REPLACEMENT SYSTEM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R