Events

Retiro De Equipo (Recall) de METAL SHELL, CEM.LESS ‘DeltaLox’ SCREW FIX., TiNb-COAT (Acetabular shell component used for hip replacement)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por RQSolutions Medical Devices Distribution Support.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00210-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-17
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00210-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The ‘deltalox’ acetabular shells have a higher than expected revision rate as reported by the australian orthopaedics association national joint replacement registry. an analysis published alongside the 2014 annual report of the aoanjrr indicates that the yearly cumulative percent revision is 5.9% at 1 year and 9.0% at 2 years. in comparison, the cumulative percent revision for other total conventional hip replacements is 1.6% at 1 year and 2.1% at 2 years. the main reasons for revision have been dislocation, loosening/lysis and fracture.
  • Acción
    Implanting surgeons are advised to schedule annual clinical and radiological examinations for patients who have been implanted with this device, in accordance with routine patient post-arthroplasty care. RQSolutions Medical Devices Distribution Support Pty Ltd is also undertaking a recall of un-implanted stock. RQSolutions has ceased supply of ‘DeltaLox’ acetabular implants and is cancelling them from the Australian Register of Therapeutic goods (ARTG). For additional information please see https://www.tga.gov.au/alert/deltalox-acetabular-shells-used-hip-implants . This action has been closed-out on 09/08/2016.

Device

METAL SHELL, CEM.LESS ‘DeltaLox’ SCREW FIX., TiNb-COAT (Acetabular shell component used for hip r...
  • Modelo / Serial
    METAL SHELL, CEM.LESS ‘DeltaLox’ SCREW FIX., TiNb-COAT (Acetabular shell component used for hip replacement)Catalogue numbers: 15800144, 15800146, 15800148, 15800150, 15800152, 15800154, 15800156, 15800158, 15800160, 15800162, 15800164, 15800166, 15800168All batch numbers affectedARTG Number: 191888
  • Manufacturer
    RQSolutions Medical Devices Distribution Support

Manufacturer

RQSolutions Medical Devices Distribution Support
  • Source
    DHTGA