Events

Recall of PyroTITAN Humeral Resurfacing Arthroplasty (CHRA)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by LMT Surgical Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00761-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00761-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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)
  • Model / 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