BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCORPIO PS TIB INSERT

    MDR report key: 1051294 · Received May 22, 2008

    Report

    Report Number
    2249697-2008-00139
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    October 28, 2004
    Report Date
    June 29, 2005
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE PATELLAR BURSITIS WAS REPORTED BY THE SITE ON A COMPLICATION FORM DATED (B) (6) 2005. CIRCUMSTANCES SURROUNDING ONSET OF THE COMPLICATION WERE DESCRIBED AS "SORE KNEE AT PATELLA." THE SEVERITY WAS LISTED AS "MODERATE" AND THE RELATION TO DEVICE AS "UNCERTAIN." THE EVENT WAS TREATED WITH ICE ON (B) (6) 2004, AND REMAINED UNRESOLVED AS OF (B) (6) 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS TIB INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 92181601

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other