BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA V-40 CERAMIC HEAD 32/0

    MDR report key: 1620570 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00671
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    March 28, 2007
    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 ARE 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (REVISION SURGERY REQUIRED AND PRODUCT CODE LZO).

    Description of Event or Problem · 1

    REVISION SURGERY REQUIRED. THIS PATIENT RECEIVED A 32 -4MM DELTA V40 CERAMIC HEAD INSTEAD OF 32 0MM AS DESCRIBED ON THE PACKAGE LABEL. THIS PATIENT WAS PARTICIPATING IN THE DELTA CLINICAL TRIAL, SO IT WAS REPORTED TO THE CLINICAL RESEARCH DEPARTMENT BY THE SURGEON, THAT THE PATIENT HAD AN EPISODE OF SUDDEN PAIN 3.5 WEEKS POST OPERATIVELY. X-RAYS REVEALED SUBSIDENCE OF FEMORAL PROSTHESIS AND A FRACTURED FEMUR RESULTING IN A REVISION OF THE RIGHT HIP PERFORMED ON (B) (6) 2006. AS A CONSEQUENCE THE PATIENT WAS WITHDRAWN FROM THE CLINICAL TRIAL. SURGEON DETERMINED THAT THE PERIPROSTHETIC FRACTURE WAS UNRELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA V-40 CERAMIC HEAD 32/0 IMPLANT LZO STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS NA 17273801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other| R