BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON #4 PS INSERT 13MM

    MDR report key: 3030319 · Received April 2, 2013

    Report

    Report Number
    0002249697-2013-01159
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    BASED ON THE VISUAL INSPECTION IT APPEARS THAT THE IMPLEMENT USED TO PUSH BACK ON THE ANTERIOR FACE OF THE INSERT COMPONENT DURING ATTEMPTED SEATING MAY HAVE COME INTO CONTACT WITH THE LOCKING WIRE. WITHOUT THE RETURN OF THE LOCKING WIRE FOR EVALUATION, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON BEHALF OF THE CUSTOMER THAT DURING SURGERY WHEN THE SURGEON WAS INTRODUCING THE INSERT INTO THE TIBIAL BASEPLATE, THE LOCKING WIRE BROKE. ACCORDING TO THE SURGEON NO STRESS WAS USED WHEN INTRODUCING THE INSERT ONLY GENTLE PRESSURE WITH A FINGER AND INSERT IMPACTOR. ANOTHER INSERT WAS USED. NO DELAYS OR ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON BEHALF OF THE CUSTOMER THAT DURING SURGERY WHEN THE SURGEON WAS INTRODUCING THE INSERT INTO THE TIBIAL BASEPLATE, THE LOCKING WIRE BROKE. ACCORDING TO THE SURGEON NO STRESS WAS USED WHEN INTRODUCING THE INSERT ONLY GENTLE PRESSURE WITH A FINGER AND INSERT IMPACTOR. ANOTHER INSERT WAS USED. NO DELAYS OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133627 TRIATHLON #4 PS INSERT 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCG319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other