BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMTEC CERAMIC INS/SLEEVE TRIDENT H

    MDR report key: 641995 · Received October 17, 2005

    Report

    Report Number
    9616680-2005-00106
    Event Type
    Injury
    Date Received
    October 17, 2005
    Date of Event
    September 15, 2005
    Report Date
    September 23, 2005
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD A PRIMARY CERAMIC TOTAL HIP ON 3/19/2004. PT DOING VERY WELL AT ONE YEAR FOLLOW-UP. THEN PT STARTED FEELING/HEARING AN AUDIBLE "CLICK" OR "CLUNK" IN HIP. THEN BECOMING MORE PAINFUL AND LOUDER. PATIENT WAS REVISED ON 9/15/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMTEC CERAMIC INS/SLEEVE TRIDENT H IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA U5192202

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention