BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-PRIM TIB BASEPLATE CEMENTED #7

    MDR report key: 1911262 · Received November 23, 2010

    Report

    Report Number
    9610726-2010-00451
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 MFR. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DOCTOR REMOVED BASEPLATE THEN RECUT TIBIA, PUT IN NEW BASEPLATE AND POLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-PRIM TIB BASEPLATE CEMENTED #7 IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA SKRTK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention