BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMTEC CERAMIC INS/SLEEVE TRIDENT G

    MDR report key: 1053474 · Received May 28, 2008

    Report

    Report Number
    9616680-2008-00133
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    P000013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "INSERT WAS PLACED INTO SHELL AND IMPACTED. IT DID NOT SEAT. AFTER CLEANING AROUND THE RIM OF THE SHELL IMPACTION WAS ATTEMPTED THREE MORE TIMES. IT DID NOT SEAT. A SECOND INSERT WAS OPENED AND IMPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMTEC CERAMIC INS/SLEEVE TRIDENT G IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 25550502

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other