BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TAPER WEDGE PRESSED FIT FEMORAL COMP.

    MDR report key: 1234657 · Received November 10, 2008

    Report

    Report Number
    2530191-2008-00006
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 8, 2008
    Manufacturer
    STELKAST, INC.
    Product Code
    LWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TWO (2) DUAL TAPER WEDGE (DTW) STEMS WERE OPENED AT A HOSPITAL SITE AND THE OUTER TYVEK POUCH WAS FOUND TO BE POSSIBLY BREACHED. THE STEMS WERE RETURNED TO STELKAST FOR EVALUATION. THE EVALUATION CONFIRMED THE APPEARANCE OF THE POSSIBLE BREACH IN THE STERILE BARRIER PACKAGING. THE RESULTING INVESTIGATION LED TO THE CONCLUSION THAT THE POSSIBLE BREACH WAS CAUSED BY THE EDGES OF THE FORGED RIBS RUBBING AGAINST THE OUTER POUCH MATERIAL. A PACKAGE BURST TEST WAS CONDUCTED ON THE ITEMS IN QUESTION AND THE TEST RESULTED IN THE PACKAGING EXCEEDING THE SPECIFIED BURST PRESSURE. A BREACH COULD NOT BEEN CONFIRMED. CONCLUSION: BECAUSE A VISUAL INSPECTION CANNOT PROPERLY IDENTIFY A BREACHED STERILE BARRIER PACKAGE, STELKAST HAS TAKEN A CONSERVATIVE APPROACH AND WILL RECALL ALL DTW STEMS FROM DISTRIBUTION. ALSO, THIS IS THE SECOND INCIDENT IN REGARDS TO A POSSIBLE BREACH IN THE STERILE BARRIER PACKAGING OF THIS DEVICE. AN ENGINEERING CHANGE ORDER WAS IMPLEMENTED AFTER THE FIRST INCIDENT TO ENHANCE THE PACKAGING. REMEDIAL ACTION WAS ISSUED ON 10/31/2008 TO INVESTIGATE AND REMOVE ALL DTW HIP STEMS. ONCE THESE ITEMS HAVE BEEN RECOVERED, THEY WILL BE REPROCESSED WITH THE REVISED PACKAGING.

    Description of Event or Problem · 1

    A POSSIBLE BREACH OF THE TYVEK STERILE BARRIER PACKAGING OF A DTW STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL TAPER WEDGE PRESSED FIT FEMORAL COMP. LWJ STELKAST, INC. SC1439 16301-042606

    Patients

    Seq Age Sex Outcome Treatment
    1