BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMTEC CERAMIC INS/SLEEVE TRIDENT G

    MDR report key: 1012990 · Received January 9, 2008

    Report

    Report Number
    9616680-2008-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2008
    Date of Event
    December 10, 2007
    Report Date
    December 10, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE PATIENT'S REP THAT, "A LOUD SQUEAKING NOISE SUBSEQUENTLY DEVELOPED WHEN PLAINTIFF AMBULATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMTEC CERAMIC INS/SLEEVE TRIDENT G IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA U7433503

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other