Page 1

PMA Mandatory for All MoM Hip Implants, FDA reports The FDA reorganized its safety communications page for metal-on-metal (MoM) hip arthroplasty implants on January 17 and issued a projected order that requires makers of MoM systems to submit premarket approval (PMA) applications. Stryker Corporation (one of the most known manufacturing companies of hip


implants) will be greatly affected by this. Mr. Stephen P. MacMillan, former Stryker CEO, left Stryker in February 2012 before a highly publicized recall of the company’s Rejuvenate, and ABG II hip replacement devices. Metal-on-metal hip implants were initially assessed under the 510(k) premarket notification program and labelled Class III devices. The FDA page was revised with information that directs orthopedic surgeons on patient selection and deliberation of alternative hip systems. It also conferred how to teach patients about the risks of MoM hip implants and their revision, and advises that surgeons


must definitely observe patients for adverse reactions after a hip replacement surgery.

These recommendations were based on evaluating the strengths and weaknesses of the implants and the works on these devices, and also the outcome of the Orthopedic and Rehabilitation Devices Advisory Panel meeting last June 2012.

The FDA proposes that an evaluation should be done every six months for patients with metalon-metal hip implants who are symptomatic. All other patients should be assessed every one


to two years, as reflected on the information in the communication.

To know more about hip replacement complications, visit Stryker hip implant recall

Sources: ryortho.com/breaking/metal-on-metal-hips-torequire-pma/ raps.org/focus-online/news/news-articleview/article/2737/pma-application-to-berequired-for-controversial-hip-devices-saysfda.aspx

PMA Mandatory for All MoM Hip Implants, FDA reports  

The FDA reorganized its safety communications page for metal-on-metal (MoM) hip arthroplasty implants on January 17 and issued a projected o...

Read more
Read more
Similar to
Popular now
Just for you