BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER TRIAL HEAD 36MM +10

    MDR report key: 2020512 · Received February 16, 2011

    Report

    Report Number
    2249697-2011-00169
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 2249697-2011-00167, 00168, 00170, 00171, 00172, 00173, 00174.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THEATRE ASSISTANT, REPORTS VIA OUR AREA EXECUTIVE ORTHOPAEDICS, THAT AFTER WASHING PROCESS DIRT STILL COMES OUT OF THE TRIAL HEADS, WHICH SHE GUESSES TO SIT BEHIND THE RING (2008-2046 TO 2208-2068). ADDITIONALLY, SHE REPORTS THAT THE TRIAL HEADS RUN IN SILVER OF THE TIME AND THEN THE SIZE IS NO LONGER READABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER TRIAL HEAD 36MM +10 INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention