BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELA V-40 CERAMIC HEAD 32/+4

    MDR report key: 1620575 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00702
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    April 24, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS
    Product Code
    LZO
    PMA / PMN Number
    K052718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION 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 IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (POST OPERATIVE ADVERSE RESULT AND PRODUCT CODE LZO).

    Description of Event or Problem · 1

    POST OPERATIVE ADVERSE RESULT. PATIENT PARTICIPATING IN (B) (6) CLINICAL TRIAL. THREE MM FEMORAL MIGRATION OF RIGHT HIP REPLACEMENT TREATED CONSERVATIVELY USING CRUTCHES FOR 4 WEEKS. PATIENT RETURNED ON (B) (6) 2007 FOR THE 12 MONTH FOLLOW UP VISIT AND REPORTED NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELA V-40 CERAMIC HEAD 32/+4 IMPLANT LZO STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS NA 17198101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other