BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT CERAMIC INSERT

    MDR report key: 1001966 · Received February 21, 2008

    Report

    Report Number
    9616680-2008-00039
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO OF THIS PER WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S REP THAT, "THE PT HAD TRIDENT CERAMIC ON CERAMIC HIP SURGERY IN 2005. SEVEN MONTHS FOLLOWING HIS PRIMARY SURGERY, HIS HIP BEGAN SQUEAKING AND POPPING. SUBSEQUENTLY, HE WAS REVISED FIVE TIME." (THIS REPORT DOCUMENTS THE 4TH REVISION.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT CERAMIC INSERT IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention