BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT PSL HA SOLID BACK 46MM

    MDR report key: 3925228 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02597
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A HAIR IN PACKAGING INVOLVING A TRIDENT SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. NO ADVERSE CONSEQUENCES TO ANY PATIENT WERE REPORTED. DEVICE EVALUATION AND RESULTS: THE OUTER BOX WAS RETURNED, WITH SHRINK WRAP COVERING ALL BUT ONE SIDE. INSIDE THE BOX, A DARK HAIR WAS OBSERVED UNDER ONE OF THE INSIDE FLAPS. 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 LOT REFERENCED. CONCLUSIONS: THE HAIR FOUND IN THE RETURNED PACKAGING COULD NOT BE CONFIRMED TO BE A MANUFACTURING RELATED ISSUE. THERE ARE CONTROLS IN PLACE ALONG WITH VISUAL CHECKS TO REDUCE THE POSSIBILITY OF THE EVENT OCCURRING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAIR IN THE CARTON. THE DOCTOR USED THE PRODUCT BECAUSE HAIR WAS NOT IN AN INNER PACKAGE, SO DOCTOR THOUGHT STERILIZATION OF PRODUCT WAS NO PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAIR IN THE CARTON. THE DOCTOR USED THE PRODUCT BECAUSE HAIR WAS NOT IN AN INNER PACKAGE, SO DOCTOR THOUGHT STERILIZATION OF PRODUCT WAS NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404129 TRIDENT PSL HA SOLID BACK 46MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 46880701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other