BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI PRESS-FIT STEM 14MM X 100MM

    MDR report key: 3821106 · Received May 20, 2014

    Report

    Report Number
    0002249697-2014-01866
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K070095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    SURGEON WAS DOING A KNEE REVISION, WHEN HE REAMED THE DISTAL FEMUR FOR STEM PREPARATION. REAMING WAS DONE AND STOPPED AT 14 MM X 100. A TRIAL STEM SIZE 14 WAS INSERTED AND FIT WAS GOOD. A SIZE 14MM BY 100MM STEM WAS OPENED AND ATTACHED TO FEMUR AND THEN WAS ATTEMPTED TO BE IMPLANTED WHEN THE STEM WOULD NOT ADVANCE INTO THE CANAL. IMPACTION WAS ATTEMPTED AND THE STEM STILL WOULD NOT ADVANCE. THE IMPLANT WAS REMOVED FROM THE FEMUR AND THE TRIAL 14 X 100 STEM WAS INSERTED AND FIT WELL, ONCE AGAIN HE TRIED THE REAL IMPLANT AND IT WOULD NEVER ADVANCE, SO A SIZE 13 X100 WAS OPENED AND IT FIT EASILY.

    Description of Event or Problem · 1

    SURGEON WAS DOING A KNEE REVISION, WHEN HE REAMED THE DISTAL FEMUR FOR STEM PREPARATION. REAMING WAS DONE AND STOPPED AT 14 MM X 100. A TRIAL STEM SIZE 14 WAS INSERTED AND FIT WAS GOOD. A SIZE 14MM BY 100MM STEM WAS OPENED AND ATTACHED TO FEMUR AND THEN WAS ATTEMPTED TO BE IMPLANTED WHEN THE STEM WOULD NOT ADVANCE INTO THE CANAL. IMPACTION WAS ATTEMPTED AND THE STEM STILL WOULD NOT ADVANCE. THE IMPLANT WAS REMOVED FROM THE FEMUR AND THE TRIAL 14 X 100 STEM WAS INSERTED AND FIT WELL, ONCE AGAIN HE TRIED THE REAL IMPLANT AND IT WOULD NEVER ADVANCE, SO A SIZE 13 X100 WAS OPENED AND IT FIT EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298446 TRI PRESS-FIT STEM 14MM X 100MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH M9C32K

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other