BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9214060 · Received October 21, 2019

    Report

    Report Number
    1818910-2019-109344
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    April 22, 2003
    Report Date
    September 30, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    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, 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, "EARLY HEAD PENETRATION INTO CEMENTED HYLAMER OGEE SOCKET" WRITTEN BY TOSHIKI IWASE, MD, HIDEKI WARASHINA, MD, KEN-ICHI YAMAUCHI, MD, SYO SUGIURA, MD, AND YUKIHARU HASEGAWA, MD PUBLISHED BY THE JOURNAL OF ARTHROPLASTY VOL. 18 NO. 7 2003 ACCEPTED FOR PUBLISHING 22 APRIL 2003 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE'S PURPOSE: "THIS STUDY WAS UNDERTAKEN TO INVESTIGATE THE EARLY PENETRATION RATE AND RADIOGRAPHIC RESULTS IN CEMENTED PRIMARY TOTAL HIP ARTHROPLASTY USING THE CEMENTED HYLAMER ACETABULAR OGEE SOCKET." DATA WAS COMPILED FROM 19 HIPS (19 PATIENTS) IMPLANTED BETWEEN MAY 1996 AND MARCH 1998 UTILIZING DEPUY PRODUCTS OF HYLAMER OGEE ACETABULAR COMPONENT, CEMENTED ELITE PLUS STEM. ALTHOUGH NOT STATED, IT IS REASONABLE TO ASSUME THE FEMORAL HEAD WAS ALSO DEPUY. NO INDICATION GIVEN REGARDING CEMENT PRODUCT. ADVERSE EVENTS: ASEPTIC LOOSENING OF FEMORAL STEM COMPONENTS TREATED WITH REVISION, ACETABULAR MIGRATION WITH OSTEOLYSIS TREATED WITH REVISION. NO INDICATION OF DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008380 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention