BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9188001 · Received October 14, 2019

    Report

    Report Number
    1818910-2019-109034
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    January 5, 2013
    Report Date
    September 25, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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, "LESSER TROCHANTERIC OSTEOTOMY IN TOTAL HIP ARTHROPLASTY FOR TREATING CROWE TYPE IV DEVELOPMENTAL DYSPLASIA OF HIP" WRITTEN BY NIRONG BAO, JIA MENG, LIWU ZHOU, TING GUO, XIAOFENG ZENG AND JIANNING ZHAO PUBLISHED BY INTERNATIONAL ORTHOPAEDICS (SICOT) (2013) 37:385¿390 DOI 10.1007/S00264-012-1758-4 ON 5 JANUARY 2013 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE'S PURPOSE: "HERE WE REVIEWED 28 CASES (30 HIPS) OF FEMORAL SHORTENING USING LESSER TROCHANTERIC OSTEOTOMY FOR CROWE IV DDH LEAVING THE GREATER TROCHANTER INTACT, AND EVALUATED THE EFFECTIVENESS AND SAFETY OF THIS PROCEDURE." THE DATA WAS COMPILED FROM 28 CASES (30 HIPS) OF THA PROCEDURES PERFORMED BETWEEN MAY 1999 TO APRIL 2010 WITH A MEAN FOLLOW UP PERIOD OF 55.3 MONTHS. THERE WERE FOUR IDENTIFIED PATIENTS ASSOCIATED WITH ADVERSE EVENTS CAPTURED INDIVIDUALLY IN LINKED COMPLAINTS. THIS COMPLAINT CAPTURES ADVERSE EVENTS WITHOUT PATIENT IDENTIFIER: A DEEP VEIN THROMBOSIS, THIGH PAIN THAT SELF RESOLVED WITHIN 6 MONTHS. THE ARTICLE DOES NOT SPECIFY WHICH PRODUCTS ARE RELATED TO THESE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982635 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention