Hip Replacement Recall: Stryker Trident implant parts
Stryker Corp. has issued a hip replacement recall for certain implant components manufactured at their Ireland plant. An internal company investigation discovered that their hip implant cups could have levels of “manufacturing residuals” which exceed company standards. This recall is not the first sign of manufacturing problems for Stryker implant components, and the lawyers at Saiontz & Kirk, P.A. are reviewing potential hip replacement lawsuits for individuals who have experienced pain, bone fractures or other serious problems after surgery.
Last week the FDA released a copy of a warning letter which was sent to Stryker in November 2007 about hip implant manufacturing problems at a different plant owned by the company in New Jersey. The FDA indicated that Stryker had received numerous complaints about their Trident hip replacement parts between January 2005 and April 2007, but failed to adequately address the problems. Following the FDA warning letter, Stryker launched an internal investigation which discovered additional problems with some products manufactured at their Ireland plant.
The hip replacement recall was issued January 22, 2008, for two products from the Stryker Trident hip implant line: the Trident Acetabular PSL Cup and the Trident Hemispherical Cup. Both products are used in the socket portion of hip replacements and the PSL version is the most commonly used of all Stryker Trident cups in the United States. The hip implants fit into the metal sockets, which help the bones in the joint move properly after replacement surgery. The components were recalled due to deviations from internal manufacturing specifications.
The company has stated that the recall only applies to the hip replacement components which have not been implanted into patients and that there are no indications the “manufacturing residuals” will require that the hip replacement parts be removed. The company claims that the parts still meet U.S and international standards for sterility and compatibility in the human body.
HIP REPLACEMENT RECALL LAWSUITS
The manufacturing problems at the Stryker plants in New Jersey and Ireland have raised concerns about the quality of hip implant products made by the company. The hip is a complex joint, and manufacturing defects in hip implant components could result in “squeaky” noises in the replacement joint, pain, discomfort, fractured bones or the possible need for additional surgery.
According to the November 2007 FDA warning letter, numerous individuals who received Stryker Trident hip replacement components have reported complaints to the manufacturer over the past three years. These complaints could be consistent with manufacturing defects, and potential hip replacement lawsuits are being reviewed nationwide for individuals who have experienced problems which could be caused by defective implant parts.
If you, a friend or family member suspect that pain, difficulty walking or fractures could be caused by defective hip implant components, the product liability lawyers at Saiontz & Kirk, P.A. can help determine if defective parts which were included in the Stryker hip replacement recall may have been used. To review a potential claim, request a free consultation.