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The Stryker Corporation has recalled its Trident PSL and Hemispherical Acetabular Cups that were manufactured in its Cork County Ireland facility. The recall came only days after the Food and Drug Administration released a letter to the company warning it to take action on consumer complaints and manufacturing processes.

The recall

Stryker has voluntarily recalled its Trident PSL and Hemispherical Acetabular Cups after testing results indicated that the products may have been deficiently manufactured in its Cork, Ireland facility. According to a press release from Stryker (www.stryker.com):

[R]esults from … testing indicated that the level of manufacturing residuals in some cases exceeded the Company's internal acceptance criteria. As a result of the deviation from internal specifications, the Company is initiating a voluntary recall of Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork facility.

New Jersey products not affected

In a letter from the Food and Drug Administration (FDA) released last week, the FDA warned Stryker about several deficiencies in the company’s Mahwah, New Jersey facility and threatened to take further action if the company did not address those deficiencies. Stryker has said that any products manufactured in its New Jersey facility are not part of its recall and are still available to consumers. However, many consumers are just as leery about the U.S. made products.

Deficiencies uncovered

The FDA uncovered several deficiencies at Stryker’s New Jersey plant which were linked to consumer complaints concerning the same products involved in the recall. It said that Stryker “failed to implement adequate corrective and preventive actions (which would include verifying or validating the corrective and preventive action to ensure that such action is effective) in order to prevent the recurrence of nonconforming product and other quality problems.”

The Administration specifically pointed to the following complaints that were received over a two year period:

• Trident Hemispherical and Trident PSL cups failed to function; hip implant components have poor fixation. In some instances, these problems have required revision surgeries.
• Squeaking noises of hip implants with ceramic bearing components; some of those problems resulted in revision surgeries due to implant failures (fractures, pain, wear particles, and fragments).
• Improper seating of hip implants in broached bones resulting in bone fractures.

To view the FDA’s letter, go to: www.fda.gov/foi/warning_letters/s6627c.htm.

If you have experienced problems with the Stryker’s Trident PSL and Hemispherical Acetabular Cups, contact an experienced attorney who has been following these issues and whose practice focuses in this area of the law to discuss your options. To contact an attorney for a free, no-obligation consultation, please click here.