The PROFEMUR Hip System Modular Necks are components used in hip replacement procedures, during which the natural hip joint is replaced by prosthetic implants. Femoral necks are designed as an interface between the femoral head (femoral ball) and the femoral stem that goes into the femoral bone. The PROFEMUR Necks are modular – they consist of multiple components that are supposed to allow for more flexibility in matching patient anatomies.
Wright Medical, the original manufacturer of the PROFEMUR Modular Necks, first received approval for these hip components in 2009 as a 510k device. The FDA’s 510k process allows manufacturers to bypass clinical testing as long as the device is similar to products currently on the market.
MicroPort Orthopedics is the current successor of Wright Medical, after MicroPort Scientific Corporation acquired Wright Medical’s orthopedic business in 2014.
On August 7, 2015, MicroPort Orthopedics sent a Voluntary Device Product Recall letter to all its customers, asking them to stop using a particular model of its PROFEMUR Modular Necks. First announced by the FDA on September 28, 2015, the recall involved almost 11,000 modular necks distributed in the U.S. between June 2009 and July 2015. Between August 2011 and January 2016, at least 79 reports of adverse events associated with the recalled model have been submitted to the FDA.
The reason for the recall was the “unexpected rate of postoperative fractures resulting in the need for revision surgery.” Such fractures can lead to hip pain and other symptoms that require revision surgery to remove the broken neck and other hip components.
Sudden fractures and associated emergency revisions can lead to serious damage, such as:
As a result, the FDA classified the recall as Class I – “the most serious type of recall… in which there is reasonable probability that… [the recalled] products will cause serious adverse health consequences or death.”
Patients implanted with the faulty PROFEMUR modular necks are advised to seek immediate medical help should they experience any of the following symptoms:
Learn more about your options for financial recovery by speaking with a product liability attorney at Kaiser Gornick LLP.