BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRS CURVED FEM STEM 17 X 127MM

    MDR report key: 3033612 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01186
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. IT IS IMPORTANT TO NOTE THAT THE PRODUCT IN THIS CASE WAS MANUFACTURED AND PACKED PRIOR TO A PACKAGING IMPROVEMENT THAT WAS IMPLEMENTED IN SEPTEMBER 2009 AS PART OF AN NCR IN RESPONSE TO A TREND IN MRS STEM PACK DAMAGE.

    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
    136201 MRS CURVED FEM STEM 17 X 127MM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH TEC259H

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other