Stryker and Zimmer Hip Implants
Stryker & Zimmer Hip Implant Recall Information
Stryker Implants
Stryker hip implants were recalled in January 2008, after the FDA sent warning letters to the manufacturer regarding patient complaints and manufacturing deficiencies. The recall included 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, and the PSL version is the most commonly used Stryker cup in the United States.
Hip implants produced at Stryker’s Ireland facility were the only ones affected by the product recall.
Zimmer Implants
In July 2008, Zimmer Holdings, the nation’s largest manufacturer of orthopedic devices, announced that it would suspend sales of its Durom Cup metal hip sockets. At that time, doctors reported a high rate of device failure, which sometimes made replacement surgery necessary.
What Problems Are Linked to Stryker & Zimmer Hip Implants?
Stryker Implants
The implants were linked to a number of problems, including:
- Squeaky hip replacement joints
- Extreme pain
- Difficulty walking
- Fractured and splintered joint implants
- Improperly fitted implants that lead to bone fractures
Zimmer Implants
The failed sockets were linked to a variety of problems, including:
- Pain
- Stiffness
- Difficulty walking/going up stairs
- Limping
Hip Implant Overview
Stryker Implants
Stryker Corp. issued a recall of its Trident Hip Implants in January 2008, after the Food and Drug Administration (FDA) posted one of two letters that it sent to Stryker online, warning the company about a variety of problems at its manufacturing plants.
The FDA began investigating Stryker after receiving a large number of complaints from patients who received the hip implants. From January 2005 through April 2007, the agency received reports of squeaking noises from hip implants with ceramic bearing components. In some instances, this required revision surgeries due to implant failures that caused fractures, pain, wear particles, and fragments. Additional complaints were received during the same time period regarding improper seating of hip implants that resulted in bone fractures.
The FDA’s first warning letter to Stryker, sent in March 2007, detailed several violations at the company’s Ireland facility, including missed deadlines to fix failures in following procedures for testing problematic products. The second letter, sent in November 2008, said that deficiencies uncovered during an inspection at Stryker’s New Jersey plant had directly contributed to the manufacture of faulty hip implants. For instance, "clusters" of Staphylococcus bacteria, the pathogen that causes staph infections was found throughout the plant. Furthermore, the letter asserted that Stryker did not perform "corrective and preventative" actions to address quality problems.
Zimmer Implants
Since it was introduced in the United States in 2006, the Durom cup has been implanted in over 12,000 patients. In April 2008, Dr. Lawrence Dorr, a Los Angeles surgeon, publicly warned other physicians about cup failures his patients were experiencing. In response, Zimmer said it would start an investigation but kept on selling the cups until sales were suspended in July of 2008.
Zimmer said their investigation found that implanting the cup required a high degree of precision. The company announced that it planned to resume sales once specialized training for doctors had begun.
Did You Know?
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