BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32MM +4 V40 TAPER VIT HEAD

    MDR report key: 1622634 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00689
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    July 12, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS
    Product Code
    KWY
    PMA / PMN Number
    K993601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 ARE 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE DID NOT FUNCTION AS EXPECTED AND PRODUCT CODE LWJ).

    Description of Event or Problem · 1

    DEVICE DID NOT FUNCTION AS EXPECTED. IT WAS REPORTED THAT, "CHRONIC DISLOCATOR REVISED ANATOMIC 40MM HEAD IN 66MM TRIDENT SHELL - AFTER CONSTRAINED LINER WAS SNAPPED INTO SHELL USUAL FASHION 32MM V-40 HEAD PLACED ON TRUNION 32MM HEAD LOCATED INTO CONSTRAINED LINER NORMAL FASHION RANGE OF MOTION TEST 90 DEGREE FLEXION SLIGHT INTERNAL ROTATION INNER CONSTRAINED LINER DISASSOCIATED FROM POLY SHELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 32MM +4 V40 TAPER VIT HEAD IMPLANT KWY STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS NA 8JDMDD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other