BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CR FEM COMP #6 R-CEM

    MDR report key: 4210949 · Received October 29, 2014

    Report

    Report Number
    0002249697-2014-04041
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: BASED ON THE VISUAL INSPECTION OF THE RETURNED PRODUCT IT APPEARS THAT THIS COMPONENT PACKAGING WAS SUBJECTED TO EXCESSIVE/INAPPROPRIATE HANDLING WHEREBY THE PACKAGING APPEARS TO HAVE BEEN IMPACTED TO THE EXTENT THAT THE OUTER BLISTER CRACKED UNDER COMPRESSIVE FORCE. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS THE EVENT IS RELATED TO A PACKAGING ISSUE AND NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. DEVICE HISTORY REVIEW: DHR REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE PACKAGING DAMAGE WAS CAUSED BY EXCESSIVE/INCORRECT HANDLING.

    Description of Event or Problem · 1

    THE NURSE AT THE CLINIC REPORTED THE FOLLOWING EVENT: "DEFECT OBSERVED ON THE FIRST STERILE PACKAGING. THE RIGID BLISTER WAS BROKEN LATERALLY WHILE THE OUTER CARTON AND PROTECTION WERE FINE."

    Description of Event or Problem · 1

    THE NURSE AT THE CLINIC REPORTED THE FOLLOWING EVENT: "DEFECT OBSERVED ON THE FIRST STERILE PACKAGING. THE RIGID BLISTER WAS BROKEN LATERALLY WHILE THE OUTER CARTON AND PROTECTION WERE FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691940 TRIATHLON CR FEM COMP #6 R-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH EFJDR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other