BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9205014 · Received October 17, 2019

    Report

    Report Number
    1818910-2019-108609
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    May 5, 2018
    Report Date
    September 27, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    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, "THE CLINICAL IMPACT OF EDOXABAN FOR THE PATIENTS WITH POSTOPERATIVE ANEMIA AFTER TOTAL HIP ARTHROPLASTY" WRITTEN BY YASUHISA IZUSHI, NAOFUMI SHIOTA, TOMONORI TETSUNAGA, KENICHI SHIMADA,TAKASHI EGAWA, TSUKASA KIUCHI, TORU SATO, RITSUGI TAKUMA, AND YOICHIRO TAKAMI PUBLISHED BY EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY HTTPS://DOI.ORG/10.1007/S00590-018-2212-0 PUBLISHED ON 05 MAY 2018 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE FOCUSES ON IMPACT OF EDOXABAN (63 PATIENTS) COMPARED TO FONDAPARINUX (86 PATIENTS) ON THA CASES WHERE DEPUY PINNACLE CUPS AND SUMMIT STEMS WERE UTILIZED IN OF ANEMIA AND REPORTS BLOOD TRANSFUSIONS WERE PROVIDED IN 19 PATIENTS IN THE EDOXABAN GROUP AND 16 PATIENTS IN FONDAPARINUX GROUP. NO FURTHER ADVERSE EVENTS ARE DISCUSSED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999616 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention