Problems with Design

stryker-hip-implant-recall-rejuvenate-hipHip replacement patient complaints referred to poor fixation or loosening requiring revision surgeries, squeaking noises (from the ceramic on ceramic joints) requiring revision surgeries due to implant failures (fractures, pain, wear particles, and fragments), and improper seating resulting in bone fractures.

FDA’s Warning Letter made no distinction between cups manufactured in Mahwah, New Jersey and those made in Cork, Ireland. Because complaints regarding cups made in both locations are received in the Mahwah, New Jersey facility and the devices are the same regardless of manufacturing location, the FDA inspector reviewed all Trident cup complaints.

Douglas L. Ellsworth, District Director of FDA’s New Jersey District Office, indicated that the company’s attempts to investigate and identify the root causes of the cup problems and implement corrective actions were inadequate, violating the Federal Quality System Regulation.

Director Ellsworth also indicated that Stryker Hip Replacement Implant recall failed to comply with the Federal Corrections and Removals Regulation by failing to inform FDA of the removal from the market of Trident PLS Acetabular Cups due to the discovery of an operator’s failure to inspect product dimensional features resulting in the release of out-of-tolerance devices. Stryker Hip Replacement Implant recall ’s technical and medical assessment stated that the discrepancy could fully or partially prevent the taper on the ceramic sleeve from locking with the taper on the cup, allowing the ceramic liner to move freely within the cup. The motion between the two metal surfaces would cause metal wear debris particles which, over time, could lead to metalosis requiring revision surgery. Metallosis is defined as loosening, aseptic fibrosis or local necrosis of an implanted device as a result of metal corrosion and release of wear debris. The released debris particles provoke a foreign-body reaction that ultimately leads to osteolysis and prosthetic loosening.

Additionally, “if compressive forces are removed from the hip, the liner may be able to slide out of the shell and dislocate the patient’s hip,” requiring revision surgery. Also, a non-solidly locked insert poses the greatest risk since it would potentially lead to immediate removal and change of the shell or premature failure due to debris. Even if the locking head were only partially captured locking strength would be compromised resulting in disassociation requiring revision surgery.

Stryker Hip Replacement Implant recall ’s Inadequate Response

hip-recallStryker Hip Implant Recall LawsuitThe November 2007 letter from the FDA was not the first warning issued to the medical device company. The November letter refers to Stryker Hip Replacement Implant recall ’s failure “to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” The FDA complains in the letter that Stryker Hip Replacement Implant recall “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”

In response to the Warning Letter, Stryker Hip Replacement Implant recall issued a press release on January 22, 2008, announcing the temporary and voluntary withdrawal from the market of Trident PLS and Hemispherical Acetabular Cups made in Cork, Ireland. The announcement indicated that product manufactured in Mahwah, New Jersey was not affected and that all Cups, regardless of place of manufacture, met all US and international performance standards for sterility and biocompatibility. Stryker Hip Replacement Implant recall explained that the withdrawn product simply deviated from internal specifications. The company added that “medical expert opinion of current and historical data concludes that there are no safety issues for patients who received these products. In fact, independent clinical evidence confirms that the performance of these cups compares very favorably with other high performing acetabular devices.”

On March 15, 2007, Tim Ulatowski, Director of FDA’s Office of Compliance for devices, issued a Warning Letter to Mr. Michael McGrath, General Manager/Vice President of Stryker Hip Replacement Implant recall Ireland, Ltd., based on a 2006 inspection of the Cork facility. The Warning referred to several packaging issues and bioburden problems with the Final Rinse Tank. Mr. Ulatowski acknowledged the anticipated completion date of February 28, 2007 of the firm’s voluntary recall of all Hip Fracture Stems.

A more recent Stryker Hip Replacement Implant recall recall , this one involving 142 US-made Trident PSL Acetabular Shells and HA (hydroxyapatite) Solid Back Acetabular Shells – distributed in the US and Brazil — was initiated August 30, 2007. The company explained that specific lots “may have a dimensional discrepancy. The deviation regarding the difference in wall thickness could increase the gap between the shell and liner on one side and while decreasing the gap between the shell and liner on the other side resulting in interference.”

Headquartered in Kalamazoo, Michigan, Stryker Hip Replacement Implant recall reported orthopedic implant sales of $3,570.7 million for the year 2007, representing an increase of 14.8% compared to 2006. The company’s total 2007 sales were $6,001 million. Founded in 1941 by Dr. Homer Stryker Hip Replacement Implant recall , today the medical technology company boasts a broad range of products in orthopedics and a significant presence in other medical specialties. Products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; and patient handling and emergency medical equipment.