BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0° X3 INSERT 32MM ID

    MDR report key: 3103335 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01602
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THAT A BUR WAS PRESENT. DEVICE HISTORY REVIEW INDICATED ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. NON CONFORMANCE WAS ISSUED FOR BURR ON TRIDENT POLYETHYLENE INSERT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THA, WHEN A SURGEON WAS ABOUT TO INSERT A X3 INSERT ON A TRIDENT CUP, HE NOTICED A BURR ON THE INSERT. THEREFORE, HE IMPLANTED ANOTHER INSERT INSTEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THA, WHEN A SURGEON WAS ABOUT TO INSERT A X3 INSERT ON A TRIDENT CUP, HE NOTICED A BURR ON THE INSERT. THEREFORE, HE IMPLANTED ANOTHER INSERT INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203022 TRIDENT 0° X3 INSERT 32MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 41626101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other