BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-CR FEMORAL COMPONENT CEMENTED #7 LEFT

    MDR report key: 2020683 · Received March 7, 2011

    Report

    Report Number
    9610726-2011-00063
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    July 16, 2008
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR.# 9610726-2011-00062.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PT HAD BILATERAL KNEE REPLACEMENTS AND HAS BEEN EXPERIENCING EXTREME PAIN. HE HAS NOT REACHED OUT TO HER SURGEON AS OF YET. HE WANTED TO KNOW IF HIS KNEE REPLACEMENTS WERE PART OF RECALL." THE SUBJECT DEVICE IS IMPLANTED IN THE PATIENT'S LEFT KNEE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-CR FEMORAL COMPONENT CEMENTED #7 LEFT IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA SHYYN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other