BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRS 17MM X 127MM FEMORAL STEM

    MDR report key: 3033628 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01184
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K040749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PACKAGING DETERMINED THAT THE PACK WAS SUBJECTED TO EXCESSIVE HANDLING LEADING TO THE STERILE PACK DAMAGE. THE EVENT WAS CONFIRMED. DHR REVIEW DETERMINED THAT THE LOT WAS MANUFACTURED AND PACKED TO SPECIFICATION. COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO SIMILAR EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE PACKAGING DAMAGE WAS CAUSED BY EXCESSIVE HANDLING.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY OPENED TWO GMRS STEMS FOR DISTAL FEMUR AND BOTH HAD DAMAGED PACKAGING. THE FIRST STEM HAD PACKAGING THAT WAS NOT SEALED PROPERLY AND THERE WAS A FILM INSIDE THE PACKAGE. THE SECOND STEM WAS OUT OF THE PACKAGING AND HAD A BROKEN SEAL. THE PACKAGING DAMAGED STERILITY, AND IMPLANT AND WERE UNABLE TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY OPENED TWO GMRS STEMS FOR DISTAL FEMUR AND BOTH HAD DAMAGED PACKAGING. THE FIRST STEM HAD PACKAGING THAT WAS NOT SEALED PROPERLY AND THERE WAS A FILM INSIDE THE PACKAGE. THE SECOND STEM WAS OUT OF THE PACKAGING AND HAD A BROKEN SEAL. THE PACKAGING DAMAGED STERILITY, AND IMPLANT AND WERE UNABLE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137017 MRS 17MM X 127MM FEMORAL STEM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH TEC1099

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other