Events

Retiro De Equipo (Recall) de Tandem Bipolar Hip System (hemiarthroplasty hip prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew Pty Ltd.

¿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-2016-RN-01167-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-06
  • 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-2016-RN-01167-1
  • 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
    Smith & nephew have identified a manufacturing error which affects certain batches. the affected devices were manufactured with a retainer groove that is out-of-specification. the out of specification condition could potentially result in one of three functional failures: the device will not assemble, the head is too tight or in rare occasions, the device may appear to be assembled properly during surgery but later disassociate post-operatively. the likelihood of implant detachment after surgery is very low. however, if it did occur, it would happen within the first few weeks after the operation and be clearly recognised by the patient (and confirmed by x-ray).
  • Acción
    Smith & Nephew is advising users that there is no recommendation for proactive revisions. Failure of the device will result in the patient experiencing pain, limited mobility or loss of range-of-motion. Surgeons should maintain their routine follow-up protocol for patients who have been implanted with a potentially affected device. Smith & Nephew is advising users to inspect stock and quarantine the affected devices for return. Affected devices can be returned for credit or replaced with unaffected product. This action has been closed-out on 24/05/2017.

Device

Tandem Bipolar Hip System (hemiarthroplasty hip prosthesis)
  • Modelo / Serial
    Tandem Bipolar Hip System (hemiarthroplasty hip prosthesis)Material Numbers: 71324041, 71324044, 71324045, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, Multiple Batch Numbers affectedARTG Number: 242993
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd