BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT PSL HA CLUSTER 50MM

    MDR report key: 3973476 · Received August 1, 2014

    Report

    Report Number
    0002249697-2014-02972
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE PRODUCT BOX, IMPLANT STICKERS, OUTER AND INNER BLISTERS, STYROFOAM, AND SHELL WERE RETURNED. THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED INDICATED THE INNER TYVEK LID WAS STUCK TO THE OUTER TYVEK LID. WHEN THE OUTER TYVEK LID WAS PEELED, THE INNER LID WAS PEELED ALONG WITH IT. THE ROOT CAUSE WAS DETERMINED TO BE A KNOWN PACKAGING ISSUE. PACKAGING INNOVATIONS IS AWARE OF THIS, AND HAS ISSUED A MEMO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, SURGEON WAS OPENING THE PACKAGES OF THE DEVICES WHICH WERE STUCK TOGETHER AND CAUSED CONTAMINATION THEY DECIDED TO USE NEW DEVICES. COMPLETED SURGERY WITHOUT ANY DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY SURGEON WAS OPENING THE PACKAGES OF THE DEVICES WHICH WERE STUCK TOGETHER AND CAUSED CONTAMINATION THEY DECIDED TO USE NEW DEVICES. COMPLETED SURGERY WITHOUT ANY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450669 TRIDENT PSL HA CLUSTER 50MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MNJY6X

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other