BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCON P-FIT STEM COCR19MMX155MM

    MDR report key: 3830820 · Received May 23, 2014

    Report

    Report Number
    0002249697-2014-01946
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 4, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K924482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IMPLANT DATE UPDATED. AN EVENT REGARDING PACK DAMAGE INVOLVING A DURACON STEM WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PACKAGING DETERMINED THAT THE PACK WAS SUBJECTED TO EXCESSIVE INCORRECT HANDLING LEADING TO THE PACK DAMAGE AND THE GENERATION OF FOAM DEBRIS WITHIN THE STERILE PACK. DEVICE HISTORY REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. COMPLAINT HISTORY REVIEW DETERMINED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE LOT. THE INVESTIGATION CONCLUDED THAT THE PACKAGING DAMAGE WAS CAUSED BY EXCESSIVE HANDLING. IT IS RELEVANT TO NOTE THAT THE COMPONENT IN QUESTION WAS PACKED IN 2009 AND THE CONFIGURATION FOR THAT PACK HAS SINCE BEEN CHANGED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    THE SURGEON REQUESTED A PRESS FIT STEM EXTENDER SIZE 19MM DIAMETER BY 155 LENGTH. WHEN THE NURSE WENT TO OPEN THE BOX AND PUT ON THE STERILE FIELD, SHE NOTICED THAT THE STERILE PACKAGING HAD BEEN COMPROMISED. AN 18MM STEM WAS USED IN ITS PLACE.

    Description of Event or Problem · 1

    THE SURGEON REQUESTED A PRESS FIT STEM EXTENDER SIZE 19MM DIAMETER BY 155 LENGTH. WHEN THE NURSE WENT TO OPEN THE BOX AND PUT ON THE STERILE FIELD, SHE NOTICED THAT THE STERILE PACKAGING HAD BEEN COMPROMISED. AN 18MM STEM WAS USED IN ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307893 DCON P-FIT STEM COCR19MMX155MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH SPTSJ

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other