BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9636319 · Received January 28, 2020

    Report

    Report Number
    1818910-2020-03140
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    April 28, 2015
    Report Date
    January 16, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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).

    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.

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "THE USEFULNESS OF THREE-DIMENSIONAL COMPUTED TOMOGRAPHY AS AN ASSESSMENT OF PERIACETABULAR OSTEOLYSIS IN REVISION TOTAL HIP ARTHROPLASTY" WRITTEN BY KYOUNG HO MOON, MD, PHD, JOON SOON KANG, MD, MAN HEE WON, MD, MYOUNG JOO PARK, MD, AND JAE HWANG CHOI, MD PUBLISHED BY HIP AND PELVIS ACCEPTED BY PUBLISHER 28 APRIL 2015 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO DETERMINE THE USEFULNESS OF THREE-DIMENSIONAL COMPUTED TOMOGRAPHY IN MEASURING PERIACETABULAR OSTEOLYSIS BY COMPARING THE REAL VOLUME OF OSTEOLYSIS IN REVISION SURGERY. DATA WAS COMPILED FROM 23 PATIENTS WHO RECEIVED REVISION SURGERY DUE TO PERIACETABULAR OSTEOLYSIS BUT DID NOT HAVE SEPTIC OSTEOLYSIS OR IMPLANT LOOSENING. ALL PATIENTS RECEIVED REVISION SURGERY BETWEEN JANUARY 2006 TO NOVEMBER 2011 AND AGE RANGE 45-65 YEARS WITH MEAN INTERVAL BETWEEN INITIAL IMPLANTATION TO REVISION WAS 13.3 YEARS. ALL IMPLANTS WERE CEMENTLESS DEPUY PRODUCTS. DEPUY PRODUCTS: DURALOC CUP, ENDURON POLY LINER, AML POROUS COATED STEM, MATERIAL OF FEMORAL HEAD IS NOT STATED ADVERSE EVENTS: REVISION FOR OSTEOLYSIS ASSOCIATED WITH POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99797 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention