BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CR FEM COMP #5 L-CEM

    MDR report key: 3289047 · Received August 15, 2013

    Report

    Report Number
    0002249697-2013-02699
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Date of Event
    July 26, 2013
    Report Date
    August 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    COMPLAINT HISTORY REVIEW REVEALED THAT THERE WERE NO OTHER EVENTS FOR THE REPORTED LOT. DEVICE HISTORY REVIEW REVEALED THAT THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. BASED ON THE VISUAL INSPECTION OF THE RETURNED PRODUCT IT APPEARS THAT THIS COMPONENT PACKAGING WAS SUBJECTED TO EXCESSIVE HANDLING WHEREBY THE PACKAGING APPEARS TO HAVE BEEN COMPRESSED TO THE EXTENT THAT THE OUTER BLISTER CRACKED UNDER COMPRESSIVE FORCE. THE INVESTIGATION CONCLUDED THAT THE PACKAGING DAMAGE WAS CAUSED BY EXCESSIVE HANDLING DURING DISTRIBUTION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING OPENING OF THE ORIGINAL PLASTIC PACKAGING IT WAS OBSERVED THAT THE PLASTIC PACKAGING HAS A CRACK AND THAT THE PACKAGING WAS ALREADY OPEN. A REPLACEMENT WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING OPENING OF THE ORIGINAL PLASTIC PACKAGING IT WAS OBSERVED THAT THE PLASTIC PACKAGING HAS A CRACK THAT THE PACKAGING WAS ALREADY OPEN. A REPLACEMENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394674 TRIATHLON CR FEM COMP #5 L-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH EBJHC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other