BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 3825275 · Received May 21, 2014

    Report

    Report Number
    0002249697-2014-01907
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A TRIATHLON BASEPLATE WAS REPORTED. THE EVENT WAS CONFIRMED. THE RETURNED OUTER BLISTER HAS THE LIP OF ONE SIDE FULLY BROKEN OFF. NO OTHER PACKAGING WAS RETURNED. DEVICE HISTORY REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. COMPLAINT HISTORY REVIEW DETERMINED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE LOT. THE RETURNED OUTER BLISTER HAS THE LIP OF ONE SIDE FULLY BROKEN OFF. NO OTHER PACKAGING WAS RETURNED FOR ANALYSIS. THE COMPLAINT DESCRIPTION STATES "THAT PART OF THE PLASTIC PACKAGE LEFT IN THE LABEL WHEN PACKAGE WAS OPENED". ONE SIDE OF THE BLISTER HAD THE FLANGE/LIP BROKEN OFF AND REMAINED ATTACHED TO THE TYVEK. THE EVENT DESCRIPTION REFERS TO THE TYVEK LID AS THE LABEL. INSPECTION OF THE ENTIRE PACKAGING OF THE PRODUCT IS REQUIRED TO DETERMINE THE ROOT CAUSE OF THIS EVENT. IT DEVICES AND/OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NURSE INFORMED SALES REP THAT PART OF THE PLASTIC PACKAGE LEFT IN THE LABEL WHEN PACKAGE WAS OPENED. WHEN THE PACKAGE WAS OPENED, ONE OF THE EDGE OF THE PLASTIC BOX WAS STUCK TO THE LABEL. THE INNER PACKAGING WAS INTACT. CUSTOMER USED THE PRODUCT. OPERATION TIME DID NOT GET LONGER.

    Description of Event or Problem · 1

    NURSE INFORMED SALES REP THAT PART OF THE PLASTIC PACKAGE LEFT IN THE LABEL WHEN PACKAGE WAS OPENED. WHEN THE PACKAGE WAS OPENED, ONE OF THE EDGE OF THE PLASTIC BOX WAS STUCK TO THE LABEL. THE INNER PACKAGING WAS INTACT. CUSTOMER USED THE PRODUCT. OPERATION TIME DID NOT GET LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303057 TRIATHLON PRIM TIB BASEPLATE - CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH EH9HA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other