BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19MM PRESS FIT BOWED STEM 200

    MDR report key: 1679100 · Received May 2, 2010

    Report

    Report Number
    2249697-2009-00991
    Event Type
    Malfunction
    Date Received
    May 2, 2010
    Date of Event
    August 7, 2007
    Report Date
    August 7, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    LZO
    PMA / PMN Number
    K022403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORP CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 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 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (COMPROMISED STERILE PACKAGE) AND PRODUCT CODE LZO. DHR AND COMPLAINT HISTORY REVIEW.

    Description of Event or Problem · 1

    STRYKER PER #(B) (4): COMPROMISED STERILE PACKAGE (BLISTER OR LID). IT WAS REPORTED THAT, "EXTERIOR PACKING INTACT, HOWEVER, THE SECOND LAYER OF INTERNAL PACKAGING WAS CRACKED. THE SEAL ON THE FIRST LAYER OF INTERNAL PACKAGING WAS NOT DISTURBED, BUT THE REP WAS CONCERNED THAT THE PLASTIC HOUSING FOR THE IMPLANT WAS CRACKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 19MM PRESS FIT BOWED STEM 200 IMPLANT LZO STRYKER ORTHOPAEDICS NA 4L4066C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA