BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO NRG PS FEMORAL #8 RIGHT

    MDR report key: 6110721 · Received November 17, 2016

    Report

    Report Number
    0002249697-2016-03650
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 21, 2016
    Report Date
    March 22, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K030978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING ISSUE INVOLVING A SCORPIO FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: BASED ON THE VISUAL INSPECTION OF THE RETURNED PACKAGING IT APPEARS THAT THIS COMPONENT PACKAGING WAS SUBJECTED TO EXCESSIVE/INAPPROPRIATE HANDLING DURING TRANSPORTATION/STORAGE WHEREBY THE PLASTIC CONTAINER OF THE IMPLANT WAS BROKEN. 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: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. THE INVESTIGATION NOTED THAT THE COMPONENT PACKAGING WAS SUBJECTED TO EXCESSIVE/INAPPROPRIATE HANDLING DURING TRANSPORTATION/STORAGE WHEREBY THE IMPLANT STERILITY WAS BREACHED AS THE PLASTIC CONTAINER WAS BROKEN, HOWEVER THE OUTER PLASTIC AND PAPER BOX WAS PROPERLY SEALED WITH NO DEFECTS. NO FURTHER INVESTIGATION FOR THIS EVENT IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE IMPLANT STERILITY WAS BREACHED AS THE PLASTIC CONTAINER WAS BROKEN THE OUTER PLASTIC AND PAPER BOX WAS PROPERLY SEALED WITH NO DEFECT. HOWEVER , THE PLASTIC CONTAINER OF THE IMPLANT WAS BROKEN.

    Description of Event or Problem · 1

    THE IMPLANT STERILITY WAS BREACHED AS THE PLASTIC CONTAINER WAS BROKEN THE OUTER PLASTIC AND PAPER BOX WAS PROPERLY SEALED WITH NO DEFECT. HOWEVER , THE PLASTIC CONTAINER OF THE IMPLANT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761978 SCORPIO NRG PS FEMORAL #8 RIGHT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH MMKWND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other