BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 3163149 · Received June 11, 2013

    Report

    Report Number
    0002249697-2013-01887
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 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: VISUAL INSPECTION: THE POWDER POUCH LOT JKT048 WAS RETURNED PARTIALLY OPENED. THE LEFT SIDE OF THE OUTER POUCH REMAINS CLOSED. THE FRONT OF THE FLAP WAS SECURED DOWN WITH TAPE. THE FOREIGN MATERIAL COULD NOT BE LOCATED HOWEVER BASED ON THE PHOTOGRAPH PROVIDED, THERE WAS FOREIGN MATTER RESEMBLING A CARDBOARD SHARD PRESENT IN THE OUTER POUCH. 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: BASED ON THE PHOTOGRAPH PROVIDED, THERE WAS FOREIGN MATTER PRESENT IN THE OUTER POUCH HOWEVER THE FOREIGN MATTER WAS NOT DETECTED IN THE RETURNED PRODUCT THEREFORE ANALYSIS WAS NOT POSSIBLE. NCR/CAPA WAS ISSUED FOR FOREIGN MATTER IN THE OUTER POUCH.

    Description of Event or Problem · 1

    DURING SURGERY, BROWNISH MATERIAL WAS FOUND INSIDE THE PACKAGE. A BACKUP DEVICE WAS USED.

    Description of Event or Problem · 1

    DURING SURGERY, BROWNISH MATERIAL WAS FOUND INSIDE THE PACKAGE. A BACKUP DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263425 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JKT048

    Patients

    Seq Age Sex Outcome Treatment
    1 Other