BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA MTK FEM MED/LARGE RIGHT

    MDR report key: 2042246 · Received March 29, 2011

    Report

    Report Number
    2249697-2011-00378
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K864632
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICES CANNOT BE PERFORMED AS HOSPITAL NEEDS THEM FOR NOW AND THE DEVICES WERE NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT / EVENT AS: MFR # 2249697-2011-00379.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING REVISION SURGERY TO POSSIBLY EXCHANGE PT'S POLYETHYLENE INSERT, THE SURGEON DISCOVERED THAT THE FEMORAL COMPONENT WAS CRACKED INTO TWO PIECES AND THE TIBIAL INSERT WAS BROKEN AS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA MTK FEM MED/LARGE RIGHT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention