BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-CR TIBIAL INSERT #4 - 13MM

    MDR report key: 2717976 · Received August 23, 2012

    Report

    Report Number
    9610726-2012-00279
    Event Type
    Injury
    Date Received
    August 23, 2012
    Date of Event
    September 20, 2010
    Report Date
    August 3, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROUTINE OFFICE VISIT 9-20-2010 DR. H. NOTED INSTABILITY IN KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-CR TIBIAL INSERT #4 - 13MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LK623

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention