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.

Clinical

A total hip replacement is a surgical procedure during which the diseased cartilage and bone of the hip joint is surgically replaced with artificial prostheses. The normal hip joint is a ball and socket joint. The socket is a “cup-shaped” bone of the pelvis called the acetabulum. The ball is the head of the thigh bone (femur). During surgery the diseased socket and ball are removed and replaced with a system that includes an acetabular shell or cup (socket) with a plastic or ceramic insert and metal or plastic ball affixed to a femoral stem.

Stryker Hip Replacement Implant recall has marketed the Trident Acetabular System since 1999. The system features a locking mechanism and several options, including cluster or solid-back shells, hydroxylapatite (HA) coating, alumina ceramic and two different polyethylene bearing surfaces, eccentric and constrained shell geometries, and Tritanium fixation.

Stryker Hip Replacement Implant recall has widely promoted its Trident Ceramic System, especially for younger, more active patients. Stryker Hip Replacement Implant recall proclaims that “laboratory and clinical data indicate that ceramic bearings may be the most significant advancement in total hip replacement wear performance, helping to reduce wear to near undetectable levels.”

The system includes the shell of cup that is implanted into the patient’s acetabulum (hip bone); a ceramic insert/titanium sleeve assembly which forms the socket; and a ceramic head or ball. The femoral stem is not shown.

The insert and head of the system are both made of alumina ceramic which, Stryker Hip Replacement Implant recall states, significantly lowers wear compared to conventional plastic-on-metal or metal-on-metal joint systems, at least “in the laboratory.”

A shrink-fit titanium sleeve encapsulates the ceramic liner which Stryker Hip Replacement Implant recall states increases the material strength of the ceramic insert compared to other ceramic inserts on the market.

However, there have been longstanding concerns that brittle ceramic material is associated with a higher fracture risk, a “squeak” phenomenon, and potentially a higher dislocation rate secondary to limited neck lengths and liner options. Stryker Hip Replacement Implant recall claims that a study involving 1635 patients have dispelled those concerns.

Yet, orthopedic surgeons in the UK reported in a 2007 issue of the Journal of Bone and Joint Surgery (British Volume) several instances of incomplete seating of the metal-backed alumina liner. A. J. Langdown and others reviewed 117 hips in 113 patients who had undergone primary total hip replacement using the Trident shell with a metal-backed alumina liner. “Of these, 19 (16.4%) were noted to have incomplete seating of the liner, as judged by plain anteroposterior and lateral radiographs. One case of complete liner dissociation necessitating early revision was not included in the prevalence figures. One mis-seated liner was revised in the early post-operative period and two that were initially incompletely seated were found on follow-up radiographs to have become correctly seated.” The surgeons went on to suggest that “there is the distinct possibility that the Trident shell deforms upon implantation, thereby preventing complete seating of the liner.”

A follow-on letter from M.K. Sayana, from Dublin’s Cappagh National ORthopaedic Hospitals asks: “Would not the surgical company recall the product if the incidence of incomplete seating is so high?”

If you or a loved one have been injured by a Stryker Hip Replacement Implant recall hip replacement, please contact us immediately. We are prepared to help you.

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Stryker Hip Replacement Implant recall filing reveals new investigation

MAHWAH, N.J., March 11 (UPI) — A New Jersey subsidiary of Stryker Hip Replacement Implant recall Corp. is under investigation for paying bribes overseas, The Washington Times reported Tuesday.

Stryker Hip Replacement Implant recall Orthopedics Inc. of Mahwah, N.J., one of five companies implicated in a $230 million kickback scheme in which physicians were paid consulting fees to endorse or prescribe their products, is being examined by the U.S. Justice Department, the newspaper reported.

A recently completed New Jersey Attorney General’s Office probe alleged the companies paid U.S. physicians lucrative fees for nominal services between 2002 and 2006.

Stryker Hip Replacement Implant recall Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

The five companies command 95 percent of the world’s market of hip and knee surgical implants.

According to the SEC filing, Stryker Hip Replacement Implant recall Orthopedics is under investigation for “possible violations of the Foreign Corrupt Practices Act,” which covers bribes made overseas, the Times reported.

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