Stryker Corporation Trident Hip Implant Recall

Stryker Hip Recall

On January 22, 2008, Stryker Corporation recalled its "Trident PSL" and "Hemispherical Acetabular Cups" used in hip replacement surgery. This recall affects the "Trident PSL" and "Hemispherical Acetabular Cups" which were manufactured in the company's Cork, Ireland manufacturing plant. The recall was announced as a response to a warning letter sent to Stryker Corporation by the Food and Drug Administration ("FDA") in November, 2007. This warning letter was issued after an inspection of Stryker Corporation's New Jersey Manufacturing Plant, and outlines the inaction of Stryker Corporation to remedy manufacturing defects of their orthopedic products. According to the FDA, Stryker's "firm has not prevented the recurrence of poor fixation of the hip implant component or prevented the failure to function which has resulted in revision surgeries." This is evidenced by "customer complaints (that) have been received for squeaking/noisy ceramic on ceramic hip joints." The results of which, according to the FDA, "may ultimately lead to the formation of a wear scar." Stryker has also received "complaints for improper seating of hip implants in broached bones resulting in bone fractures." Stryker Corporation has been receiving complaints since 2005.

Products Recalled

The recall affects only Trident Acetabular PSL and the Trident Hemispherical Cups manufactured in Ireland. According to the FDA, Stryker has received complaints that "Trident PSL failed to function and hip implant components with poor fixation which have required revision surgeries." Additionally, there could be "moderately severe complication(s) which may require revision surgery either to remove loose fragment(s) or conceivably to replace the component entirely."

Sterility in Manufacturing

Another serious issue mentioned in the FDA's Warning Letter regards sterility issues in the Stryker's NJ Plant. According to the FDA, increased levels of bacteria (Staphylococcus spp) were found in Stryker's NJ manufacturing Plant. The warning letter was sent as "no corrective actions were performed by (Stryker) in order to prevent the recurrence of out-of-specification microbiological results received from (their) purified water and air monitoring samples for the implant final cleaning and packaging areas that are used for (their) sterile implantable devices... (Stryker) has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence."

Questions and Consultations

If you or a family member have a Stryker-made hip implant and have experienced squeaking noises of the ceramic bearing components or implant failures (fractures, pain, wear particles, and fragments)or have needed a replacement of your Stryker hip implant due to mechanical defects, please contact your physician immediately. If you would like to discuss your rights, please fill out the free case evaluation form and a member of Seeger Weiss LLP's experienced staff will call you to discuss your potential rights concerning Stryker Hip Replacements. Attorney consultations incur no obligation on your part. All initial consultations are free of charge and do not create an attorney-client relationship.