Hip Replacement Complications

Osteoarthritis, or damage to the cartilage that cushions the ends of bones, is one of the primary reasons for hip replacement surgery. The design and longevity of prosthetic joints has made great strides since 1940, when the first hip replacement procedure was offered at Johns Hopkins hospital. Orthopedic manufacturers have developed a variety of new artificial hip systems to accommodate a younger, more active demographic, with the promise of increased durability and range of motion.

Some of these devices have enjoyed great commercial success and patient reviews, while others – particularly metal-on-metal models — have been associated with severe and debilitation hip replacement complications such as dislocation, corrosion, fretting, metal poisoning and other problems that necessitate revision surgery.

No matter what type of implant is used, hip replacement surgery is a fairly invasive procedure carrying the following risks:

• Blood clots and pulmonary embolism
• Bone fracture
• Change in leg length
• Infection in the joint
• Dislocation
• Nerve damage
• Loosening of the device
• Persistent pain
• Need for a new hip replacement

FDA cautions about metal-on-metal hip dangers

In 2013, U.S. health regulators at the FDA issued a safety communication on the possible complications of metal-on-metal (MoM) hips, including resurfacing and total hip replacement systems. The agency warned that MoM implants have unique risks in addition to traditional devices made with ceramic, plastic or other materials.  Case studies on such devices have shown that metal components have a tendency to shed tiny metal particles as the parts connect during normal movement.  According to the FDA, this fretting can result in injury to the surrounding tissue and bone – a complication known as an adverse local tissue reaction (ALTR).

“Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions),” states the agency.

Infection, loosening, osteolysis, femoral neck fractures and tissue necrosis are all potential risks linked with MoM devices such as the DePuy ASR hip replacement system, which was recalled in August of 2010 for these very same concerns.

DePuy ASR and Pinnacle hip complications

The DePuy ASR XL Acetabular total hip replacement sported an innovative design consisting of a metal femoral head and a one-piece metal cup that lines the acetabulum. In March 2010, DePuy’s parent company Johnson & Johnson admitted that the ASR device suffered higher than average failure rates, with roughly 12 percent of recipients needing revision surgery within a couple of years. A voluntary recall was issued in 2010, more than 16 months after the first lawsuit was filed against the company.

Since then, thousands more have followed, alleging problems such as:

• Systemic illness caused by metal contamination
• Tissue damage
• Early loosening of the device
• Pseudutomors
• Chronic inflammation
• Bone necrosis
• Persistent pain and reduced mobility
• Fractured bones

DePuy Orthopaedic’s metal-on-metal version of its Pinnacle hip replacement system, using the Ultamet liner, has also been blamed for incapacitating complications caused by wear and tear on metal components.  While the device remains on U.S. markets, DePuy discontinued the Ultamet metal liner for use with the Pinnacle hip implant in May 2013.

As a prime example of alleged Pinnacle hip replacement complications, one recent lawsuit filed in California Superior Court states that device failed prematurely, causing pain and numbness that has severely impacted the claimant’s ability to perform daily activities such as walking. The plaintiff had been implanted with two Pinnacle devices and needed bi-lateral hip revision surgery to remove the implants a short time later.

Stryker hip recalls and replacement problems

Other industry leaders include Stryker Orthopaedics and Howmedica Osteonics Corporation, manufacturers of the now recalled Rejuvenate and ABG II hip systems.  Cleared for commercial sale by the FDA in 2008 and 2009 respectively, both systems were found to fret and corrode on the modular neck-stem junction, causing pain, swelling and the type of adverse tissue reactions which the FDA now warns about.

The ABG II and Rejuvenate implants were recalled in 2012 due to concerns with:

• Disproportionately high failure rates
• Corrosion and fretting
• Metallosis (blood poisoning)
• Adverse tissue reactions
• Pain and immobility
• Need for early revision surgery

The Rejuvenate was not the first hip implant recall issued by Stryker. The company had also withdrawn from sale its Trident Acetabular PSL and Trident Hemispherical cups in 2008 due to manufacturing defects found in its Cork, Ireland facility.

Adverse events reported by Trident patients included:

• Improper bone seating
• Squeaking and popping noises
• Device failure and breakage
• Excruciating pain
• Broken bones

Adverse reports from Zimmer Durom Cup recipients

Launched by Zimmer Corporation in 2006, the Durom Cup hip replacement features a single monoblock design, which was supposed to reduce the potential grinding effects of a ball and socket or modular neck junction. However, just two years after its release, the company suspended sales of the Durom Cup based on numerous complaints of high revision rates and a lack of bone in-growth causing a separation of the implant from the hip bone. In addition to chronic discomfort, many Durom Cup patients reported decreased mobility and dislocation of the device.

Zimmer re-released its product with revised surgical instructions several weeks later, claiming the Durom Cup’s failure rates were attributed to poor surgical technique rather than design flaws.  Hundreds of patients who have taken legal action against Zimmer beg to differ, arguing that due to a lack of bone in-growth, the hip replacement system loosened, requiring immediate corrective surgery.

Other problematic hip replacement systems

• Wright Medical Technology – The company’s metal-on-metal Conserve and Profemur systems have been associated with bone and tissue damage, infection, pseudotumors, dislocation, metallosis and early hip implant failure.
• Biomet Orthopedics – Common problems linked with the metal-on-metal M2a Magnum Hip Replacement system include severe pain, loosening and dislocation of the joint and premature failure.
• Smith & Nephew – The R3 Acetabular systems featured a MoM version that was recalled in June 2012. In addition, the Birmingham resurfacing device has also been tied to reports of swelling, pain, and toxic metal contamination.

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