BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 44MM NO 0

    MDR report key: 3211233 · Received July 8, 2013

    Report

    Report Number
    0002249697-2013-02226
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING SEAL INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS CONFIRMED. THE DEVICE AND ALL OF THE PACKAGING EXCEPT FOR THE SHRINK WRAP WAS RETURNED. THE INNER TYVEK IS DELAMINATED. THE OUTER TYVEK AND THE INNER TYVEK HAVE BEEN COMPLETELY PEELED BACK SHOWING THAT THE SEAL FLANGES ARE COMPLIANT. A DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. THE INVESTIGATION CONCLUDED THAT THE INNER TYVEK IS DELAMINATED WHEN THE OUTER TYVEK IS OPENED BECAUSE THE INNER TYVEK IS STUCK ON THE OUTER SEAL FLANGE AT THE BOTTOM RIGHT CORNER OF THE BLISTER. THE TOLERANCE ON THE INNER TYVEK AND THE INNER BLISTER ALLOWS TO 1-2 MM OUT OF THE CORNER SEAL FLANGE. AN NC HAS BEEN RAISED TO INVESTIGATE THIS EVENT FURTHER.

    Description of Event or Problem · 1

    AN EXETER 44 0 STEM WAS OPENED BY THE THEATRE STAFF. WHEN OPENING THE OUTER PAPER PEEL IT WAS STUCK TO THE INNER PAPER PEEL WHICH STARTED TO PEEL THE INNER PAPER PEEL. DUE TO THE UNUSUAL SITUATION, THE STERILITY OF THE PACKAGING WAS CALLED INTO QUESTION. ANOTHER 44 0 STEM WAS OPENED SUCCESSFULLY.

    Description of Event or Problem · 1

    AN EXETER 44 0 STEM WAS OPENED BY THE THEATRE STAFF. WHEN OPENING THE OUTER PAPER PEEL IT WAS STUCK TO THE INNER PAPER PEEL WHICH STARTED TO PEEL THE INNER PAPER PEEL. DUE TO THE UNUSUAL SITUATION THE STERILITY OF THE PACKAGING WAS CALLED INTO QUESTION. ANOTHER 44 0 STEM WAS OPENED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310177 EXETER V40 STEM 44MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G3612341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other