BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-CR FEMORAL COMPONENT CEMENTED #4 LEFT

    MDR report key: 2070950 · Received April 19, 2011

    Report

    Report Number
    9610726-2011-00112
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    MBH
    PMA / PMN Number
    K051380
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS ENROLLED IN THE (B)(4) STUDY. THE SITE SUBMITTED THE PREVIOUS IMPLANT INFORMATION FORM INDICATING THAT A (B)(4), FEMORAL AND PATELLAR COMPONENTS WERE REVISED. THE SITE NOTED, IT WAS AN ASEPTIC FAILURE OF THE KNEE, SPECIFICALLY THE FEMORAL COMPONENT. HOWEVER, THE DEVICES THAT WERE EXPLANTED ARE NOT AVAILABLE AND ARE NOT COLLECTED AS PART OF THE STUDY. THE TRIATHLON TS DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-CR FEMORAL COMPONENT CEMENTED #4 LEFT IMPLANT MBH STRYKER ORTHOPAEDICS LIMERICK NA SJYEF

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention