BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° POLY INSERT 28MM ID

    MDR report key: 3875102 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02289
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 23, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K983502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE DAMAGE OBSERVED ON THE ARTICULATING SURFACE OF THE TRIDENT LINER ARE DUE TO ARTICULATION OF THE FEMORAL COMPONENT ON THE INSERT. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION SURGERY AFTER COMPLAINING ABOUT PAINFUL HIP. IT WAS REPORTED THAT THERE WAS ECCENTRIC POLY WEAR ON THE POLY LINER. THE SURGEON TOOK THE LINER AND HEAD OUT AND REPLACED A 36G X3 LINER WITH A 36+10 COCR HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION SURGERY AFTER COMPLAINING ABOUT PAINFUL HIP. IT WAS REPORTED THAT THERE WAS ECCENTRIC POLY WEAR ON THE POLY LINER. THE SURGEON TOOK THE LINER AND HEAD OUT AND REPLACED A 36G X3 LINER WITH A 36+10 COCR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352075 TRIDENT 0° POLY INSERT 28MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 03348601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention