Stryker Hip Replacement
Stryker Hip Replacement Side Effects Could Result In Personal Injury Lawsuits
Stryker Hip Replacement | Lawyers, Lawsuits | Side Effects: Pain, Difficulty Walking, Squeaky Joints | Defective Device, Faulty Hip Implants, Plant Contamination
On November 28, 2007, Stryker Corp., a leading maker of hip replacements and other joint replacement components, received a warning letter from the Food & Drug Administration (FDA) regarding deficient and unsanitary conditions at the Stryker manufacturing facility in Mahwah, New Jersey. The FDA warning letter resulted from an inspection of the Stryker plant that occurred in the summer of 2007, and marked the second time the FDA had told Stryker to correct the deplorable conditions at the New Jersey manufacturing facility.
In responding to the FDA warning letter, Stryker maintained that it did not believe there is any clinical evidence to indicate that the products mentioned in the Warning Letter present a safety issue to patients.” However, the FDA warning letter had stated that Stryker had received complaints about hip implant components made at the Mahwah facility dating back to 2005. Outrageously, in the same press release in which Stryker defended the quality of its products, the company announced a recall of two defective Trident hip implant components. Though they were not made at the plant cited in the FDA warning letter, the recall of the Trident components raised serious questions about the quality controls employed by Stryker.
Stryker FDA Warning Letter
According to the November 28, 2007 FDA warning letter, Stryker had been receiving complaints about components made at the Mahwah, New Jersey factory since 2005. Those complaints included hip joints that did not fit properly, an issue which caused recipients to experience a range of problems, including pain, difficulty walking and “squeaky” joints. Some patients even reported that pieces of their implants had broken off , and others had worn unevenly. The FDA warning letter said that the deficiencies uncovered at the Mahwah facility had contributed directly to the manufacture of these faulty hip implants.
During its 2007 inspection, the FDA found a range of problems at Stryker’s New Jersey plant. Among the most serious where instances of bacterial contamination at the Stryker plant. The contamination included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections. The November 28 letter marked the second time Stryker was warned by the FDA about these problems. The warning letter faults Stryker for sending the FDA inadequate responses to the initial warning between August 1 and November 1, 2007. 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.
Trident Hip Implant Component Recall
On January 22, 2008, Stryker Corp. announced that it was recalling two hip implant components made under the company’s popular Trident line. Ironically, the recall announcement was made in the same press release Trident used to respond to allegations in the November 28, 2007 warning letter. The Stryker Hip Implant component recall involved two hip replacement cups made at the company plant in Cork, Ireland. The recall involved the Trident Acetabular PSL Cup and the Trident Hemispherical Cups. 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 these components could be contaminated with “manufacturing residuals” at levels that exceeded company standards
Legal Help For Victims Affected By Stryker Hip Replacement
Parker Waichman LLP is currently evaluating possible product liability lawsuits against Stryker Corp. for the defective hip implants and other joint implant components manufactured at its New Jersey plant. If you or a loved on were seriously injured as a result of a defective Stryker Hip Implant, you may have valuable legal rights. Please fill out our online form or call our office a 1-800-968-7529 for a free case evaluation by a qualified medical device attorney.