BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT HEMISPHERICAL SOLID BK 50MM

    MDR report key: 4322373 · Received December 11, 2014

    Report

    Report Number
    0002249697-2014-04589
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 12, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PACKAGING ISSUE INVOLVING A TRIDENT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED, NO PACKAGING OR DEVICES WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE REPORTED PACKAGING IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. PRODUCT DISPOSED AT HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER STERILE PACKAGING WAS STUCK TO INNER STERILE PACKAGING. SURGEON WAS NOT HAPPY USING IT. PER ADDITIONAL INFORMATION FROM THE REP: NO ADVERSE EVENT AS ANOTHER PRODUCT WAS AVAILABLE FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER STERILE PACKAGING WAS STUCK TO INNER STERILE PACKAGING. SURGEON WAS NOT HAPPY USING IT. PER ADDITIONAL INFORMATION FROM THE REP: NO ADVERSE EVENT AS ANOTHER PRODUCT WAS AVAILABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805017 TRIDENT HEMISPHERICAL SOLID BK 50MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 47190101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other