STRYKER HIP REPLACEMENT COMPLICATIONS

Here's another interesting post contributed by Drugwatch.

Stryker Hip Replacement Complications

Around 450,000 hip replacement surgeries are done every year, giving people relief from pain and allowing them to once again participate in everyday activities.

Stryker Orthopaedics is one of the leading manufacturers of hip implants, which are often required as a result of osteoarthritis, arthritis, trauma, obesity, bone death or other hip conditions.

Two of Stryker's popular hip implants, the Rejuvenate and the ABG II, were designed to be long-lasting and provide a custom fit for patients. Unfortunately, many patients instead required painful and expensive revision surgeries to replace the implants.

Stryker’s implants can lead to complications like metal poisoning, bone tissue death and chronic pain. In July 2012, the manufacturer recalled the two hip implants.

Serious Complications

The unique design of Stryker's Rejuvenate and ABG II gives surgeons freedom to customize implants for individual patients using several neck and stem components. The neck components are made of chromium and cobalt, and the stems are coated with titanium. The necks and stems meet at a metal-on-metal junction, which can release metallic debris into the body during normal movement.

Metallic debris can affect the tissue around the implant, turning it a grey color as the tissue becomes oxygen-starved and begins to die. If patients have metal sensitivity, this can be particularly dangerous, leading to metal poisoning. Metal ions in the blood can also cause emotional imbalance, severe headaches, and cognitive and nervous system problems.

Other complications resulting from metal debris can include:

·         Formation of cysts or pseudotumors

·         Implant failure

·         Implant loosening

·         Deterioration of bone around the implant

·         Osteolysis (bone lost around implant that leads to inflammation)

·         Severe joint pain

When patients experience these or other complications from implants, they may need revision surgery to remove the defective implants.

Safety Alert and Recall

More than 20,000 people received the Rejuvenate or ABG II before Stryker issued a warning about the implants in April 2012. A few months later, Stryker recalled the two hip systems.

The April warning, classified as an "Urgent Safety Alert," stated that the implants were associated with "fretting and/or corrosion at or about the modular neck junction," that can "lead to increased metal ion generation in the surrounding joint space." It was sent to hospital risk managers and surgeons.

Meanwhile, dozens of implant recipients had reported adverse events, like metal toxicity, to the Food and Drug Administration (FDA).

Finally, on July 6, 2012, Stryker recalled the Rejuvenate and ABG II, and stopped global production and marketing of the implants. Stryker says that patients who have received these devices and are suffering from side effects should seek medical attention. Medical professionals can provide evaluations using X-rays, MRIs and blood tests to determine if metal ion levels are too high.

There are more than 50 Stryker lawsuits pending in New Jersey state court, and hundreds more claimants are expected to step forward in the coming months.

Alanna Ritchie is a content writer for Drugwatch.com, specializing in news about prescription drugs, medical devices and consumer safety. Feel free to follow us on Twitter.