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.