BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI TS BASEPLATE SIZE 3

    MDR report key: 2142414 · Received June 21, 2011

    Report

    Report Number
    2249697-2011-00925
    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
    K053514
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IT ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON REVISED UNI TO TKA WITH UNIVERSAL BASEPLATE AND 5MM WEDGE. SURGEON COMMENTED THAT IT MAY HAVE SUBSIDED. PT EXPERIENCED PAIN." THE EXACT IMPLANTATION DATE WAS NOT PROVIDED, HOWEVER, IT WAS INDICATED THAT THE REPORTED DEVICE WAS IMPLANTED IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI TS BASEPLATE SIZE 3 IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA VFXFA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention