cialis online

Defective Stryker Hip Implants Lead to Complaints, Recalls

AddThis Social Bookmark Button

What is going on at Stryker Corp?  In just nine months, the company has received two Food & Drug Administration (FDA) warning letters about problems its New Jersey and Cork, Ireland manufacturing plants. Then, just last month defective Stryker hip implant components made at the  Ireland plant were recalled.  Clearly, Stryker is having some pretty serious quality control problems.

Just a few days after the Stryker hip implant recall, Stryker President and CEO, Stephen P. MacMillan tried to assure investors that there was no clinical evidence to suggest safety problems with the company’s products.  Still, even he had to concede there are serious problems at Stryker. “You don’t get two letters in nine months and feel good,” MacMillan told his audience.

The FDA decided to take a hard look at Stryker after receiving an unusually high number of complaints from recipients of Stryker hip implants. Since 2005, Styker hip implant patients have reported a range of problems, including pain, difficulty walking and “squeaky” joints, and some have had pieces of implant parts break off or wear down unevenly. Those complaints prompted the FDA to inspect both the Mahwah, New Jersey and Cork, Ireland plants where most of the Stryker hip implants sold in the US are made. Those inspections resulted in the FDA issuing Stryker two warning letters.

The first, a seven-page letter dated March 15, 2007, cited several violations at the Ireland plant, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk. The heavily redacted letter refers to an earlier voluntary recall of “hip fracture stems” which appears to be related to the problems. It also cited several instances where the “root cause” of problems that caused that particular recall was not determined.

Then Stryker received another letter regarding the New Jersey facility. That letter, dated November 28, 207 said that the deficiencies uncovered during an inspection at the Mahwah, New Jersey facility had contributed directly to the manufacture of faulty hip implants. The FDA letter described a range of deficiencies, including “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections, that was found throughout the plant. The November 28 letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

Stryker’s problems came to a head on January 22, 2007, when the company issued a recall for more hip implant components made in the Cork, Ireland plant. The latest Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S.

The Trident Hip Implant cup recall was implemented by Stryker amid concerns that the components could be contaminated with “manufacturing residuals” at levels that exceed company standards. However, Stryker maintained that the problems did not affect the sterility of the components, and claimed that patients who have received the recalled Trident components will not need to have them replaced.

« »

Leave a Reply

You must be logged in to post a comment.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!
defective-hip-replacement.com

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!
CAT-Scans-Radiation-Exposure.com

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.
WaterContaminationFrom Fracking.com

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to PCBs.com

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!
TallisPhoto.com

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!
nursing-home-blog.com

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!
www.oil-rig-spills.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com