BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON #2 PS INSERT 11MM

    MDR report key: 3051299 · Received April 10, 2013

    Report

    Report Number
    0002249697-2013-01242
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THERE IS A SIGNIFICANT INDENTATION EVIDENT OVER THE WIRE RETAINING SLOT ON THE ANTERIOR FACE OF THE RETURNED COMPONENT AND UNDER THE SLOT TO ONE SIDE, WHEREBY THE FEATURE IS DEFORMED, MOST LIKELY AS A RESULT OF A SHARP IMPLEMENT BEING USED TO PUSH BACK OR LEVER THE COMPONENT. THE INSERT COMPONENT IS NOT USEABLE IN THE CONDITION IN WHICH IT WAS RETURNED. THE EVENT AS REPORTED WAS CONFIRMED. DHR REVIEW FOR THE REPORTED LOT WAS SATISFACTORY. CHR REVIEW FOR THE REPORTED LOT CONFIRMED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE LOT. BASED ON THE FINDINGS OF THE VISUAL INSPECTION, THE DAMAGE AND DEFORMATION ON THE INSERT COMPONENT WAS MOST LIKELY CAUSED DURING THE ATTEMPTED SEATING. THE COMPONENT IS NOT USEABLE IN THE CONDITION IN WHICH IT WAS RETURNED.

    Description of Event or Problem · 1

    DURING THE SURGERY AND FITTING TEST, IT WAS FOUND THAT WIRE PART ON FRONT OF LATERAL WAS NOT SEATED WELL. THE PRODUCT HAS NOT BEEN IN CONTACT WITH SOFT TISSUE.

    Description of Event or Problem · 1

    DURING THE SURGERY AND FITTING TEST, IT WAS FOUND THAT WIRE PART ON FRONT OF LATERAL WAS NOT SEATED WELL. THE PRODUCT HAS NOT BEEN IN CONTACT WITH SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148365 TRIATHLON #2 PS INSERT 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LDA093

    Patients

    Seq Age Sex Outcome Treatment
    1 Other