BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 3171353 · Received June 14, 2013

    Report

    Report Number
    0002249697-2013-01925
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FOREIGN MATTER FOUND IN THE OUTER POWDER POUCH INVOLVING SIMPLEX BONE CEMENT WAS REPORTED. THE EVENT WAS CONFIRMED. THE PRODUCT WAS NOT IMPLANTED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE POWDER POUCH LOT JAU003 WAS RETURNED OPENED AND THE FOREIGN MATERIAL WAS FOUND IN A PLASTIC BAG WITHIN THE OUTER POUCH. THE FOREIGN MATERIAL WAS BROWN IN APPEARANCE. MATERIAL ANALYSIS ON THE FOREIGN MATTER CONCLUDED THAT THE RETURNED FOREIGN MATERIAL WAS OBSERVED NOT TO BE FIBROUS AND HAD A BEST FIT MATCH TO STARCH WITH INDICATIONS THAT AN AMIDE MATERIAL COULD BE PRESENT. PAPER MATERIALS ARE KNOWN TO CONTAIN STARCH IN ADDITION TO CELLULOSE. -DEVICE HISTORY REVIEW: DHR REVIEW WAS SATISFACTORY. -COMPLAINT HISTORY REVIEW: CHR REVIEW CONFIRMED THAT THERE WERE NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. CONCLUSIONS: THE FOREIGN MATERIAL WAS BROWN IN APPEARANCE. MATERIAL ANALYSIS ON THE FOREIGN MATTER CONCLUDED THAT THE RETURNED FOREIGN MATERIAL WAS OBSERVED NOT TO BE FIBROUS AND HAD A BEST FIT MATCH TO STARCH WITH INDICATIONS THAT AN AMIDE MATERIAL COULD BE PRESENT. PAPER MATERIALS ARE KNOWN TO CONTAIN STARCH IN ADDITION TO CELLULOSE. NCR/CAPA WAS ISSUED FOR FOREIGN MATTER IN THE OUTER POUCH.

    Description of Event or Problem · 1

    DURING SURGERY, WHEN THE INNER POUCH WAS BEING REMOVED FROM THE OUTER POUCH, A SMALL BROWN PARTICLE WAS FOUND ON THE INNER POUCH. A BACKUP DEVICE WAS USED.

    Description of Event or Problem · 1

    DURING SURGERY, WHEN THE INNER POUCH WAS BEING REMOVED FROM THE OUTER POUCH, A SMALL BROWN PARTICLE WAS FOUND ON THE INNER POUCH. A BACKUP DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271112 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JAU003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other