Events

Rappel de PyroTITAN Humeral Resurfacing Arthroplasty (CHRA)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par LMT Surgical Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00761-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00761-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    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