BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI CS INSERT TRI SZ1 11MM

    MDR report key: 2142654 · Received June 21, 2011

    Report

    Report Number
    2249697-2011-00931
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME PATIENT/EVENT AS MFR # 9610726-2011-00218.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "IMPLANTED #1 9MM CS INSERT AFTER CEMENT HARDENED, THE KNEE WAS A LITTLE LOOSE IN FLEXION/EXTENSION. DR. (B)(6) EXPLANTED #1 9MM IMPLANT. THERE WAS NO CONCERN WITH THE IMPLANT ITSELF. THE DOCTOR THEN PUT A #1 11MM CS INSERT TRIAL IN THE PATIENT. THE CS #1 11MM INSERT TRIAL CRACKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI CS INSERT TRI SZ1 11MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 29945

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other