BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTOR

    MDR report key: 2112239 · Received April 29, 2011

    Report

    Report Number
    2249697-2011-00592
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 5, 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
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO FOR LOT # IS CYN06A. DATE OF MANUFACTURE FOR LOT # CYN06A: 02/22/2005. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    STRYKER REPRESENTATIVE IN (B)(4) REPORTED THAT "DURING THE INSTALLATION OF THE FEMORAL COMPONENT IMPACTOR CRUMBLED. THIS EVENT OCCURRED DURING A SURGICAL PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL IMPACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA CYK02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other