Research shows that around 20 million Americans have osteoarthritis, which often occurs in the hip joint. Osteoarthritis is a clinical syndrome in which low-grade inflammation results in pain in the joints, caused by abnormal wearing of the cartilage that covers and acts as a cushion inside joints and destruction of synovial fluid that lubricates those joints. The condition is characterized by pain while walking, standing and bearing weight; stiffness in the joints and decreased mobility. In cases where the cartilage gets thinned due to osteoarthritis, a hip replacement surgery may be unavoidable.
Stryker offers a large range of orthopedic components that are used for surgical implants. However, the company has had problems with its hip devices since January 2005 when it began receiving complaints from patients who had received the implants. The problem was two-fold involving serious defects in the manufacturing as well as the designing process. Frequent problems necessitated FDA intervention in the matter. The FDA inspected the company facilities at New Jersey and Ireland, from where most of the Stryker hip implants to the US are produced.
In its first letter, the FDA cited several violations at the Cork plant, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk. In its second letter, FDA warned Stryker about its failure to implement adequate corrective and preventive actions in order to prevent recurrence of non-conforming product and other quality problems. In response to the FDA warning, Stryker announced a hip implant recall & knee implant recall of two Trident implant parts: the Trident Actabular PSL Cup and the Trident Hemispherical Cup.