BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 4210954 · Received October 29, 2014

    Report

    Report Number
    0002249697-2014-04048
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT KNEE COMPONENTS ON THE PATIENT'S LEFT KNEE WERE REPLACED WITH TRIATHLON TS IMPLANTS. COMPONENTS WERE EXPLANTED. (B)(6) 2014: THE SALES REP INDICATED THE REASON FOR THE REVISION WAS POOR INITIAL POSITION OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691384 TRIATHLON PRIM TIB BASEPLATE - CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R