BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9189307 · Received October 14, 2019

    Report

    Report Number
    1818910-2019-109350
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    January 1, 2015
    Report Date
    September 26, 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 CONTRIBUTING FACTORS OF TAPERED WEDGE STEM ALIGNMENT DURING MINI-INVASIVE TOTAL HIP ARTHROPLASTY" WRITTEN BY SHINYA HAYASHI, TAKAAKI FUJISHIRO, SHINGO HASHIMOTO, NORIYUKI KANZAKI, RYOSUKE KURODA AND MASAHIRO KUROSAKA PUBLISHED BY JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH (2015) 10:52 DOI 10.1186/S13018-015-0192-X WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE'S PURPOSE: "IN THIS STUDY, WE DETERMINED THE ABSOLUTE DIFFERENCE BETWEEN THE STEM ALIGNMENT ESTIMATED BY SURGEONS INTRAOPERATIVELY AND THAT MEASURED USING POSTOPERATIVE CT AND EVALUATED THE CONTRIBUTION FACTORS OF STEM MALALIGNMENT DURING TOTAL HIP ARTHROPLASTY." THE DATA WAS COMPILED FROM 110 HIPS IN 21 MEN AND 89 WOMEN WHO RECEIVED THA BETWEEN JANUARY 2001 AND MARCH 2012 WITH SUMMIT STEMS (58 HIPS) AND BETWEEN APRIL 2012 AND DECEMBER 2013 WITH TRILOCK STEM (52 HIPS). NO INFORMATION PROVIDED ON ACETABULAR COMPONENTS OR THE FEMORAL HEADS. IT IS NOTED OF ONE CASE OF INTRAOPERATIVE CALCAR FRACTURE WITH A TRILOCK STEM. NO INFORMATION PROVIDED REGARDING INTERVENTIONS BUT GIVEN THE ANATOMICAL LOCATION IT IS REASONABLE TO CONCLUDE THE SURGEON PROVIDED ONE. NO OTHER ADVERSE EVENTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978212 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention