BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PKR BASEPLATE #2 RM/LL

    MDR report key: 2115072 · Received May 26, 2011

    Report

    Report Number
    2249697-2011-00775
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HRY
    PMA / PMN Number
    K071881
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE LISTED IN THIS REPORT. TRIATHLON PKR INSERT X3 #2 RM/LL - 12MM, CAT# 5630-G-222, LOT 2PXMAE. TRIATHLON PKR FEMUR #1 RM/LL, CAT# 5610-F-102, LOT WPZY. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT PAIN. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PT HAD A PKR PUT IN APPROX ONE YEAR AGO FOR MEDIAL COMPARTMENT PAIN. SHORTLY AFTER THE INITIAL SURGERY, SHE COMPLAINED OF LATERAL SIDE PAIN. AFTER CONSERVATIVE TREATMENT, THE SURGEON WENT IN AND REPLACED THE PKR FEMORAL COMPONENT WITH A SCORPIO NRG PRIMARY PS FEMORAL COMPONENT AND THE PKR TIBIAL COMPONENT WITH A SCORPIO 7000 TS BASEPLATE AND A NRG PS INSERT. THE PKR COMPONENTS WERE NOT LOOSE. THE SURGERY WAS ROUTINE AND THE SURGEON WAS HAPPY WITH THE RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PKR BASEPLATE #2 RM/LL IMPLANT HRY STRYKER ORTHOPAEDICS MAHWAH NA ZKUNA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention