BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CR TIBIAL INSERT TRIAL #4 - 9MM

    MDR report key: 2950942 · Received February 8, 2013

    Report

    Report Number
    0002249697-2013-00604
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING A FRACTURED TRIATHLON STANDARD INSERT TRIAL WAS REPORTED. THE EVENT WAS CONFIRMED. INSPECTION INDICATED THE DEVICE FRACTURED IN AN OVERLOAD CONDITION. DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW INDICATED THERE HAS BEEN SIMILAR REPORTED EVENTS FOR THIS LOT ID. THE INVESTIGATION CONCLUDED THE REPORTED EVENT IS THE RESULT OF A DESIGN ISSUE. TO ADDRESS THIS ISSUE, A DESIGN CHANGE OCCURRED IN 2010 TO OBSOLETE THIS PRODUCT AND CREATE A NEW REPLACEMENT PRODUCT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INSTRUMENT BROKE DURING SURGERY. THE SURGEON WAS ABLE TO USE ANOTHER TRIAL INSERT FOR THE BROKEN CR TRIAL.

    Description of Event or Problem · 1

    INSTRUMENT BROKE DURING SURGERY. THE SURGEON WAS ABLE TO USE ANOTHER TRIAL INSERT FOR THE BROKEN CR TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54708 CR TIBIAL INSERT TRIAL #4 - 9MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH PPM3J04

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other