Events

Safety Alert Or Field Safety Notices for DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by manufacturer #17429.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2007/054
  • Event Number
    CON2031467
  • Date
    2007-06-14
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031467
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Unexplained groin pain. the need for early revision due to periprosthetic soft tissue necrosis. the ultima tps femoral stem and ultima metal-on-metal articulation (femoral head plus metal acetabular cup) is a total hip replacement system that has been on the market in the uk since 1997. the ultima tps femoral stem is still available but the ultima metal-on-metal femoral head and acetabular cup were discontinued in 2005. up to april 2007, one uk study has reported 43 revisions (from a cohort of 637 hips) associated with extensive periprosthetic soft tissue necrosis. some also involved late dislocation or periprosthetic fracture. the revisions were required one to seven years after implantation. there have been no other confirmed reports. when these stems were explanted, extensive corrosion was observed on the surface of many of them within the area of the cement mantle. this level of corrosion of cemented polished cobalt chromium molybdenum stems has not previously been reported in the orthopaedic literature and the explanation for it is unclear. depuy has already communicated this information to uk hospitals that implanted these devices. a copy of their letter, including recommendations for imaging and patient management, is in the appendix.
  • Action
    Refer patients with this implant combination who present with unexplained groin pain for MRI scan. This is in line with the parameters recommended by DePuy (see recommendations for patient management under ‘Action’ in the appendix). Patients with abnormal signs should be considered for an early revision. Report all revisions of metal-on-metal articulations where corrosion and/or periprosthetic soft tissue reaction are observed to the implant manufacturer and the MHRA.

Device

DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation
  • Model / Serial
  • Product Description
    Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. These components were only sold in combination in the UK, France and Italy.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429