A Voluntary Recall Of Knee Replacement Implants
Added: (Thu Dec 11 2008)
Pressbox (Press Release) -
In January 2008, Stryker Corporation, one of the world's pioneers in orthopedic implants and other medical devices issued a voluntary recall of its knee and hip replacement implants. The origin of the Stryker recall can be traced back to 2005, when a large number of patients who had received Stryker implants complained of a wide range of problems like pain and difficulty in walking, squeaking joints, wear down of implant components and fractures etc. Some of these patients even had to undergo the pain and expense of revision surgeries to rectify the faulty implant components.
On-going patient complaints necessitated FDA investigation into the matter.
The FDA inspected the Stryker facility plants at New Jersey and Cork in Ireland. Their investigations revealed serious lapses in following procedures for quality control and documenting risk. In March 2007, the FDA in its initial warning letter, cited violations at the Ireland plant, including inability to fix failures in following set procedures for testing problematic components and controlling risk. A few months later, in November 2007, the FDA reprimanded Stryker for its failure to implement adequate corrective and preventive measures to prevent the recurrence of non-conforming components and parts.
In 2008, Stryker announced a voluntary hip and knee replacement recall. In a press release, Stryker while defending the quality of its components also announced the knee and hip implant recall. The Stryker recall was issued for two components from the Trident line: the Trident Acetabular PSL Cup and the Trident Hemispherical Cup. The knee replacement recall raised grave concerns over the level of quality controls employed by Stryker.
If you or your family member has had a Stryker component surgically implanted and suspect it to be defective, believe it has failed, or feel that it needs to be removed, consider a qualified lawyer to discuss your concerns. As per the provisions of the medical negligence act, you have valuable legal rights and are entitled to even receive compensation for the inconvenience caused on account of the defective implant.