BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM BEAD PA SZE3 BP

    MDR report key: 2133734 · Received June 9, 2011

    Report

    Report Number
    9610726-2011-00200
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L 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 FEELS THAT THE TIBIAL BASEPLATE WAS WAY UNDERSIZED. THE DOCTOR ALSO FEELS THAT THE PT'S WEIGHT IS AN EXACERBATING FACTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PRIM BEAD PA SZE3 BP IMPLANT MBH STRYKER ORTHOPAEDICS LIMERICK NA SALYN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention