BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON STD NEUT TIB INS 9MMMD

    MDR report key: 1802568 · Received August 10, 2010

    Report

    Report Number
    2249697-2010-01031
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K920034
    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 REVISED DEVICES CANNOT BE PERFORMED AS THEY WERE KEPT BY THE PATIENT AND WERE NOT RETURNED TO THE MFR. ADD'L INFO INCLUDING X-RAYS AND MEDICAL RECORDS WAS NOT MADE AVAILABLE. IF DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2010-01032.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT PRESENTED WITH SWELLING AND PAIN IN LEFT KNEE. X-RAYS REVEALED POLY WEAR. UPON OPENING KNEE POLY WAS WORN POSTERIOR MEDICAL. TRAY WAS LOOSE - PROCEEDED WITH FULL TRIATHLON T/S REVISION. PHYSICIAN DENIED REQUEST FOR X-RAYS OR CHART OR IMPLANTS DUE TO PT CONFIDENTIALITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON STD NEUT TIB INS 9MMMD IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UEXWA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention