BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON #4 CR INSERT 9MM

    MDR report key: 2931345 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00358
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE SIGNIFICANT MARKS AND INDENTATIONS ON THE INSERT COMPONENT INCLUDING MARKS ON THE INFERIOR AND POSTERIOR SURFACES OF THE COMPONENT, WHICH IS EVIDENCE THAT THE INSERT COMPONENT CAME INTO CONTACT WITH SOME FORM OF RESISTANCE DURING THE ATTEMPTED POSITIONING AND LOCKING OF THE INSERT INTO THE BASEPLATE COMPONENT. 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. THE INVESTIGATION CONCLUDED THAT THE SEATING ISSUE WAS CAUSED BY AN OBSTRUCTION ENCOUNTERED BY THE INSERT COMPONENT WHILE TRYING TO ENGAGE THE COMPONENT WITH THE BASEPLATE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHEN POLY WAS INSERTED IT WOULDN'T SIT DOWN ON THE MEDIAL ANTERIOR SIDE. THERE WAS NOTHING IN ITS WAY (IE NO CEMENT CAUGHT IN TRAY). IT WAS IF THE WIRE WOULDN¿T GO PAST THE LITTLE TAB ON THE ANTERIOR LIP OF THE TRAY. IT WAS STILL WOULDN'T UP AND DOWN ANTEROMEDIALLY, IT WAS REMOVED AND A NEW POLY WAS PUT IN, WHICH LOCKED DOWN WITH NO DRAMAS.

    Description of Event or Problem · 1

    WHEN POLY WAS INSERTED IT WOULDN'T SIT DOWN ON THE MEDIAL ANTERIOR SIDE. THERE WAS NOTHING IN ITS WAY (IE, NO CEMENT CAUGHT IN TRAY). IT WAS AS IF THE WIRE WOULDN'T GO PAST THE LITTLE TAB ON THE ANTERIOR LIP OF THE TRAY. IT WAS STILL POSITIONING UP AND DOWN ANTEROMEDIALLY, IT WAS REMOVED AND A NEW POLY WAS PUT IN, WHICH LOCKED DOWN WITH NO DRAMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36961 TRIATHLON #4 CR INSERT 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LDA383

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR