BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CR FEM COMP #2 L-CEM

    MDR report key: 4093891 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03510
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEMOGRAPHIC UPDATED AND IMPLANT DATE UPDATED.AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS. 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. MEDICAL RECORDS RECEIVED AND EVALUATION NOT PERFORMED AS THE EVENT IS RELATED TO A PACKAGING ISSUE. 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 INVESTIGATION CONCLUDED THAT THE PACKAGING DAMAGE WAS CAUSED BY EXCESSIVE/INCORRECT HANDLING. NO FURTHER INVESTIGATION FOR THIS EVENT IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    DURING INSPECTION OF PRODUCT FOR TOTAL LEFT KNEE REPLACEMENT, NURSE OPENED INNER BOX AND PLASTIC LOOKED CRACKED AND BROKEN. THEREFORE, STERILITY OF THE PRODUCT WAS IN QUESTION. SURGEON USED ANOTHER COMPONENT AND COMPLETED SURGERY WITHOUT ANY DELAYS.

    Description of Event or Problem · 1

    DURING INSPECTION OF PRODUCT FOR TOTAL LEFT KNEE REPLACEMENT, NURSE OPENED INNER BOX AND PLASTIC LOOKED CRACKED AND BROKEN. THEREFORE, STERILITY OF THE PRODUCT WAS IN QUESTION. SURGEON USED ANOTHER COMPONENT AND COMPLETED SURGERY WITHOUT ANY DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571163 TRIATHLON CR FEM COMP #2 L-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH S9LRJ

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other