BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9189242 · Received October 14, 2019

    Report

    Report Number
    1818910-2019-109340
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    August 19, 2009
    Report Date
    September 26, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "ANTIBIOTICS-IMPREGNATED CEMENT SPACERS IN THE FIRST STEP OF TWO-STAGE REVISION FOR INFECTED TOTALLY REPLACED HIP JOINTS: REPORT OF TEN TRIAL CASES" WRITTEN BY KATSUYUKI DAIRAKU, MICHIAKI TAKAGI, HIROYUKI KAWAJI, KAN SASAKI, MASAJI ISHII, AND TOSHIHIKO OGINO PUBLISHED BY THE JOURNAL OF ORTHOPAEDIC SCIENCE J ORTHOP SCI (2009) 14:704¿710 DOI 10.1007/S00776-009-1406-Z 19 AUGUST 2009 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE'S PURPOSE WAS TO DISCUSS ANTIBIOTIC IMPREGNATED CEMENT SPACERS (NON DEPUY PRODUCT) AND IT IS NOTED ONE CASE OF INFECTION IN WHICH THE SPACER WAS UTILIZED CONTAINED A DEPUY OGEE CUP AND C-STEM. IMPLANTS WERE REMOVED AND INFECTED TISSUES DEBRIDED ALONG WITH PULSATILE LAVAGE WITH SALINE SOLUTION FOLLOWED BY IRRIGATION WITH POVIDONE-IODINE MIXED PHYSIOLOGICAL SALINE AND HYDROGEN PEROXIDE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977901 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention