Events

Retiro De Equipo (Recall) de PyroTITAN Humeral Resurfacing Arthroplasty (CHRA)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por LMT Surgical 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-2013-RN-00761-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-08
  • 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-2013-RN-00761-1
  • 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 manufacturer, ascension orthopedics, has received complaints of implant fractures that were observed post-operatively and required revision surgeries. most confirmed cases of implant breakage have occurred as a result of excessive loading and within a year of being implanted. excessive loads placed on the implant through high impact activities or sudden trauma can damage an artificial joint, particularly in the presence of poor bone stock. high impact activity may cause loosening or fracture of the implant. the breakage can result in glenohumeral joint pain and possible damage to the surrounding tissues.
  • Acción
    The implanting surgeons are advised that the affected patients should be followed up in accordance to standard clinical practices with radiographic evaluation of the shoulder being conducted at each follow-up visit. LMT Surgical Pty Ltd is advising that future supply of the product in Australia will not occur before appropriate corrective actions are implemented. It is expected that this corrective action will take several months to complete. For more details, see http://www.tga.gov.au/safety/alerts-device-pyrotitan-130812.htm

Device

PyroTITAN Humeral Resurfacing Arthroplasty (CHRA)
  • Modelo / Serial
    PyroTITAN Humeral Resurfacing Arthroplasty (CHRA) Product Codes:CHRA-910-38/14-WW (Size 38-14)CHRA-910-41/15-WW (Size 41-15)CHRA-910-41/18-WW (Size 41-18)CHRA-910-44/16-WW (Size 44-16)CHRA-910-44/19-WW (Size 44-19)CHRA-910-44/17-WW (Size 47-17)CHRA-910-47/20-WW (Size 47-20)CHRA-910-50/18-WW (Size 50-18)CHRA-910-50/21/WW (Size 50-21)CHRA-910-53/19-WW (Size 53-19)CHRA-910-53/22-WW (Size 53-22)CHRA-910-56/21-WW (Size 56-21)ARTG: 149178
  • Manufacturer
    LMT Surgical Pty Ltd

Manufacturer

LMT Surgical Pty Ltd