BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V40 COCR LFIT HEAD 36MM/0

    MDR report key: 3840952 · Received May 30, 2014

    Report

    Report Number
    0002249697-2014-01976
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED INDICATED THE FOAM WAS STUCK TO THE INNER TYVEK LID. THE INNER TYVEK LID HAD BEEN PULLED BACK, REVEALING THE FOAM WAS STUCK TO THE LID. THE TOP SURFACE OF THE FOAM WAS REMOVED FROM THE FOAM AND REMAINED ATTACHED TO THE LID.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

    HOSPITAL STAFF OPENED PACKAGING ON PRODUCT REF. 6260-9-136 LOT MMNWVA, AND NOTICED THAT THE INNER FOAM PACKAGING MATERIAL WAS STUCK TO THE OTTER PACKAGE. AT THAT POINT HE QUESTIONED THE INTEGRITY OF THE PACKAGING AND ANOTHER FEMORAL HEAD WAS USED IN ITS PLACE.

    Description of Event or Problem · 1

    HOSPITAL STAFF OPENED PACKAGING ON PRODUCT REF. 6260-9-136 LOT MMNWVA, AND NOTICED THAT THE INNER FOAM PACKAGING MATERIAL WAS STUCK TO THE OTTER PACKAGE. AT THAT POINT HE QUESTIONED THE INTEGRITY OF THE PACKAGING AND ANOTHER FEMORAL HEAD WAS USED IN ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318608 V40 COCR LFIT HEAD 36MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MMNWVA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other