BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-CR FEMORAL COMPONENTCEMENTED #6 LEFT

    MDR report key: 2150630 · Received June 23, 2011

    Report

    Report Number
    9610726-2011-00219
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHILE PERFORMING PRIMARY KNEE REPLACEMENT, THE PT'S MCL POPPED AND THE SURGERY WAS REVISED TO A TS IMPLANT SYSTEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-CR FEMORAL COMPONENTCEMENTED #6 LEFT IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA SY8RT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention