BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA V-40 CERAMIC HEAD 36/+7,5

    MDR report key: 3941298 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02780
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K052718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT RELATING TO A PACKAGING/LABELLING ISSUE INVOLVING A CERAMIC HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. -DEVICE EVALUATION AND RESULTS: THE OUTER BOX, SHRINK WRAP, BLISTERS, TYVEKS, FOAMS AND DEVICE WERE RETURNED. THE SHRINK WRAP WAS TORN ON ONE SIDE. THE FLAP OF THE OUTER BOX THAT HAD BEEN OPENED LOOKED FRAYED. THE OUTER TYVEK HAD BEEN PEELED BACK AND THERE WAS EVIDENCE OF A COMPLETE SEAL BETWEEN THE OUTER TYVEK AND OUTER BLISTER. THE INNER TYVEK AND INNER BLISTER WERE SEALED. THE OUTER AND INNER BLISTERS WERE WARPED AND MISSHAPEN, IT WAS NOT POSSIBLE TO REMOVE THE INNER BLISTER FROM THE OUTER BLISTER. 2 OF THE 5 LABELS LOOK SLIGHTLY BLURRED AND SHINY, SUGGESTING THE DEVICE MAY HAVE BEEN CAUGHT IN A SHRINK WRAPPER. 3 OF THE 5 LABELS LOOK LIKE THEY HAVE BEEN PHOTOCOPIED AND OVER-LABELLED. THE EVENT IS RELATED TO A PACKAGING ISSUE, NO ADVERSE CONSEQUENCES TO THE PATIENT WERE IDENTIFIED AND DEVICE WAS NOT IMPLANTED. -DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED HOWEVER THE PACKAGING MANUFACTURING TEAM CONCLUDED THAT THE DEVICE WAS PACKAGED IN ACCORDANCE WITH THE MANUFACTURING AND ASSEMBLY PROCEDURES. IT WAS ALSO DETERMINED THAT THIS ISSUE WAS NOT GENERATED THROUGH THE PACKAGING MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY SURGERY OF RIGHT HIP. DOCTOR WENT TO OPEN FEMORAL HEAD COMPONENT, INNER WRAPPING OF PACKING WAS COMPLETELY MELTED. DOCTOR COULD NOT OPEN INNER PACKAGE. NO DELAY IN SURGERY

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY SURGERY OF RIGHT HIP. DOCTOR WENT TO OPEN FEMORAL HEAD COMPONENT, INNER WRAPPING OF PACKING WAS COMPLETELY MELTED. DOCTOR COULD NOT OPEN INNER PACKAGE. NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418208 DELTA V-40 CERAMIC HEAD 36/+7,5 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 47206201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other