BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO U-DOME PATELLA

    MDR report key: 2142429 · Received June 21, 2011

    Report

    Report Number
    2249697-2011-00921
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K972967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR DUE TO HOSPITAL POLICY. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2011-00920.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT DEVELOPED LATERAL LAXITY. INSERT WAS REPLACED WITH 21MM TS INSERT. PATELLA WAS REPLACED, WEAR WAS IDENTIFIED BY DOCTOR AND HE WANTED TO REPLACE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO U-DOME PATELLA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention