On May 5, 2008, the FDA issued its third warning letter to hip replacement manufacturer Stryker Corporation regarding serious issues with its hip implant devices. The letter, which can be found at here, focuses on Stryker’s biotech division in Hopkinton, Massachusetts, which manufactures products which promote bone growth, used in prosthetic devices implanted without cement.
The warning discusses issues regarding the division’s handling of clinical studies, its quality system, medical device reporting procedures, and falsification of documentation approving implantation.
The FDA also found that Stryker’s control processes for insuring the quality of its products, and reporting of complaints and adverse events related to its products are severely lacking and in violation of federal law. The warning further indicates that Stryker illegally introduced its OP-1 Implant and OP-1 Implant Putty into commerce without obtaining approval from the FDA, and failed to investigate and report adverse events with the device as required by law.
On January 22, 2008, Stryker Corp. issued a recall of its ceramic Trident Acetabular PSL Cup and Trident Hemispherical Cups. Trident Acetabular Cups are used in the socket portion of hip replacement components. The PSL version is the most commonly used Stryker hip replacement component in the U.S. The Stryker hip recall involved prosthetic components which were manufactured at Stryker’s Cork, Ireland plant due to concerns of possible contamination. The recall was issued after Stryker received two warning letters from the FDA regarding conditions at their manufacturing facilities in Ireland and Mahwah, New Jersey.
The first FDA warning letter of March 15, 2007 discussed several Stryker implant problems including the Duracon and Scorpio knee replacement components, the Trident Acetabular System, Restoraration Modular Revision Hip System, the Accolaade Cemented Hip System, the Accolade Femoral Hip System and the Dall-Miles Reconstruction and Trauma Cable System. An inspection of the Ireland facility had revealed that the devices were adulterated in that their manufacture, packing, storage or installation were not in comformity with the Current Good Manufacturing Practice requirements of the U.S. Code of Federal Regulations. The letter complained of several testing problems and failure to document risk. The letter discusses an earlier voluntary Stryker hip recall, and cites several instances where Stryker failed to determine the cause of the hip replacement problems.
The second FDA warning letter, issued November 28, 2007, which can be viewed at http://www.fda.gov/foi/warning_letters/s6627c.htm specifically targeted the Mahwah, New Jersey facility, citing problems discovered during an inspection of the plant, including discovery of Staphylococcus bacteria clusters throughout the plant. The letter warns Stryker for its failure to perform corrective actions in order to prevent the recurrence of nonconforming product or other quality problems, including failure to identify the root cause of the Staphylococcus contamination. The letter also addresses Stryker’s failure to implement corrective procedures in response to numerous reports of problems with the Trident hip implant, including delamination of the plasma sprayed coating on the device, poor fixation or failure to adhere to bone requiring hip revision surgery, improper seating of the device resulting in bone fracture, wear and fracture of the device. The tendency of Trident hip implants to squeak when in motion is also a very common problem with the device.
Increasing evidence of a potentially catastrophic problem with Stryker’s ceramic on ceramic hip replacement has also arisen recently. A medical journal article published recently in the Journal of Arthroplasty reported a high incidence of Stryker’s Trident Hip Implant recipients experiencing squeaking, popping and other noises during simple walking, which are not only highly annoying, but also raise concerns about the possibility of future shattering of the ceramic prosthesis, which could send numerous inflammatory shards into a patient’s tissues, causing extreme consequences.
HDH is experienced in handling Stryker lawsuits, as well as many other hip replacement lawsuits stemming from the widespread failure of implant devices. If you or someone you know has had a Stryker implant device surgically installed and believe it has failed, was defective, needs to be removed, or hahave already had hip revision surgery, you should have your potential case reviewed by contacting the hip implant recall attorneys at HDH. If you do not know the manufacturer of your implant, call your surgeon and get a copy of your hospital medical chart.
Please retain your orthopedic surgeon's office chart, the operative reports for the original joint replacement surgery and the revision surgery, the device record for the original surgery from the hospital chart and insist that your surgeon retain the removed prosthetic device after revision surgery and deliver to you to preserve as evidence.