BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 1405992 · Received June 17, 2009

    Report

    Report Number
    2249697-2009-00353
    Event Type
    Injury
    Date Received
    June 17, 2009
    Date of Event
    May 20, 2009
    Report Date
    May 20, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF AVAILABLE IT WILL BE SUBMITTED IN THE SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 2249697-2009-00352.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "NO EXPLAINABLE EVENT THAT PREDISPOSED PT TO SEE DR OTHER THAN DISCOMFORT. RADIOGRAPHS INDICATED PATELLAR LOOSENING. UPON PATELLAR REVISION, IT WAS NOTED THAT AT LEAST ONE PEG HAD SHEARED OFF AND ANOTHER POSSIBLY FRACTURED OFF. IT WAS ALSO NOTED THE AMOUNT OF WEAR AND PITTING NOT ONLY ON THE PATELLA BUT ALSO THE TIBIAL INSERT. DR THOUGHT THAT POCK MARKS MAY RESEMBLE OXIDATION POSSIBLY. BOTH COMPONENTS WERE REVISED WITHOUT COMPLICATION AND RETURNED TO CORPORATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON CR X3 TIBIAL INSERT IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA K1JMDD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention