Sterility Issues Prompt Stryker Hip Implant Recall

This article covers problems with Stryker Corporation hip implants that led to the 2008 recall of the company’s Trident PSL and Hemispherical Acetabular Cups models. For a discussion about Stryker’s 2012 hip implant recall, click here for an updated article.

Michigan’s Stryker Corporation has recalled its Trident PSL and Hemispherical Acetabular Cups that are used in hip replacement surgery. The recall was in response to a letter that was recently released by the Food and Drug Administration warning the company of deficiencies in a New Jersey facility; however, the recall only affects products made in Ireland.

Sterility issues

Patients with Stryker’s acetabular cups, which are used in the sockets of hip replacement components, are affected by the recall – but only for cups that were manufactured in the company’s Cork, Ireland facility. The company said that it is voluntarily recalling the Trident PSL and Hemispherical Acetabular Cups after testing showed issues with manufacturing residuals that affect the sterility of the products. However, Stryker denies that these issues “present a safety issue to patients.” According to a press release on its website (www.stryker.com), Stryker said:

It is important to note this in no way impacts the product's sterility, nor product conformance to U.S. and international biocompatibility standards. 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. Medical expert opinion of current and historical data concludes that there are no safety issues for patients who received these products.

Prior to the recall, Stryker issued a press release last week saying it was looking into problems in its Ireland plant.

In response to FDA warning letter

The recall was in response to a letter sent to the company by the Food and Drug Administration (FDA) that detailed an inspection of the company’s Mahwah, New Jersey facility in the summer of 2007 which uncovered a host of problems that the company needs to address. Those include complaints about cups failing to function, squeaking noises with ceramic bearing components, improper seating of hip implants that resulted in bone fractures and others. Some patients were forced to undergo additional surgeries due to these issues.

Although the same products associated with the recall are also made in its New Jersey facility, Stryker has not included those in the recall. To view the company’s press release, see their website (www.stryker.com). To view the FDA’s letter to Stryker, go to: www.fda.gov/foi/warning_letters/s6627c.htm.

What to do

If you have been injured by one of the above products or are concerned about the recall, contact an attorney whose practice focuses in this area of law for a free, no-obligation consultation. To contact a qualified attorney, please click here.

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