BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CR FEM COMP #7 L-CEM

    MDR report key: 4241410 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04213
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. 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 COMPRESSED FROM THE SIDES 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

    DURING SURGERY AND IMPLANTS BEING OPENED, THE CIRCULATING NURSE NOTICED, INTERNAL PACKAGING WAS NOT INTACT AND SURGEON OPTED TO NOT USE THE IMPLANTS DUE TO QUESTIONABLE STERILITY.

    Description of Event or Problem · 1

    DURING SURGERY AND IMPLANTS BEING OPENED, THE CIRCULATING NURSE NOTICED, INTERNAL PACKAGING WAS NOT INTACT AND SURGEON OPTED TO NOT USE THE IMPLANTS DUE TO QUESTIONABLE STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721722 TRIATHLON CR FEM COMP #7 L-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH SS3EJ

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other