BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV. UNIVERSAL CEMENT RESTRICTOR

    MDR report key: 1621861 · Received February 5, 2010

    Report

    Report Number
    2249697-2009-00952
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    November 13, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    LZN
    PMA / PMN Number
    K931847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORP CONDUCTED A 2 YR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (4) 2006 TO (B) (4) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE ARE 3 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE BROKE OR DISASSEMBLED DURING USE) AND PRODUCT CODE LZN.

    Description of Event or Problem · 1

    DEVICE BROKE OR DISASSEMBLED DURING USE. IT WAS REPORTED THAT "THE PLASTIC IS NOT AS FLEXIBLE AS IT WAS, VERY STIFF. OUTER RINGS BROKE OFF AS THE CEMENT RESTRICTOR WAS PUSHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RV. UNIVERSAL CEMENT RESTRICTOR IMPLANT LZN STRYKER ORTHOPAEDICS NA 6M7122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other