BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMTEC CERAMIC INS/SLEEVE TRIDENT D

    MDR report key: 1060537 · Received June 12, 2008

    Report

    Report Number
    9616680-2008-00147
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    P000013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED, AND IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT THAT SHE "IS CONCERNED ABOUT MEDIA COVERAGE OF THE CERAMIC HIP." SHE HAS A CERAMIC ON CERAMIC HIP REPORTS THAT SHE "IS EXPERIENCING A GRINDING NOISE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other