BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON P/A PS BEADED #6R

    MDR report key: 2110168 · Received May 19, 2011

    Report

    Report Number
    9610726-2011-00167
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    MBH
    PMA / PMN Number
    K051380
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A TRIATHLON TOTAL KNEE REPLACEMENT, THE SIZE 6 TRIATHLON FEMUR WAS OPENED BY THE SCOUT ONTO THE STERILE FIELD TO THE SCRUB NURSE, THE SCRUB NURSE IMMEDIATELY INSPECTED THE IMPLANT BEFORE PLACING ON INSERTION DEVICE, A SMALL SCRATCH/MARK APPROXIMATELY 5MM LONG WAS NOTICED ON THE MEDIAL (RIGHT) FEMORAL CONDYLE. A NEW FEMORAL IMPLANT WAS AVAILABLE AND OPENED TO REPLACE SCRATCHED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON P/A PS BEADED #6R IMPLANT MBH STRYKER ORTHOPAEDICS LIMERICK NA SK9CA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other