Stryker Hip Replacement and the FDA

Do you have a Stryker Rejuvenate or Stryker ABG II metal-on-metal hip replacement device? Did you know that Stryker voluntarily recalled these metal hip replacement systems after receiving numerous complaints of devastating side effects?

If you are someone who had received one of these devices, or if you suspect your hip implant may be a Stryker product, please refer to the following page as a general guide on Stryker hip replacements and the FDA.

Contact a dedicated Stryker hip replacement attorney for answers to your specific questions. Price Benowitz LLP can help you find a well-qualified attorney who can review all the facts of your case and give you an honest assessment of your potential claim.

Price Benowitz LLP does not handle Stryker Hip Replacement cases, but we can help you find a qualified attorney who can review your case. Under certain circumstances, we may take joint-responsibility of the case. Call to learn more.

History Between FDA and Stryker

Stryker’s Rejuvenate and ABG II hip systems were cleared via the US Food and Drug Administration’s (FDA) 510(k) clearances program. This submission formula allows manufacturers to bypass clinical trials if their device is similar enough to a device that has already received FDA approval. Since Stryker’s devices resembled in principle other metal-on-metal prosthetic hip devices, the FDA allowed this 510(k) submission.

However, due to numerous reports of serious medical complications and the ensuing FDA investigation, Stryker was forced to issue a voluntary recall of both products in July, 2012.

In the announcement issued by Stryker, the company “Stryker Orthopaedics’ decision to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate global distribution of these products comes after continued post-market surveillance. The post-market surveillance data may be predictive of a trend.”

If you have received a defective Stryker hip system and have experienced injuries and illness including fractures, metal-poisoning, fretting or corrosion, or other medical issues that necessitate surgical intervention you will need to contact an experienced lawyer immediately.

Even if you have not yet suffered these symptoms or complications, you should still contact a qualified attorney to discuss your options.

Lawsuits filed against Stryker thus far allege a number of harms and losses suffered. The most common accusation is that the two Stryker hip implants that have been subjected to a global recall by the company tend to fray, corrode, and fail prematurely, prompting the need for replacement or revision surgeries much earlier than anticipated. Other allegations include:

  • The manufacturer did not properly test the devices;
  • Rejuvenate and ABG II devices can corrode, deteriorate, and cause severe metal toxicity in patients;
  • The manufacturer was negligent by not properly warning doctors and patients of the dangers the device posed, including heavy metal poisoning after the systems frayed and metal shards were deposited in surrounding blood, bone, and tissues that, in turn, lead to severe side effects and, in some cases, permanent damage;
  • Both recalled Stryker systems contain serious design and manufacturing defects and can cause severe and permanent harm to patients;
  • The manufacturer knew, or should have known, that the product was inherently dangerous;
  • Stryker aggressively marketed the product, and willfully misled the public by not informing consumers about the risks.

Conditions Linked to Stryker Hip Replacements

The two Stryker hip systems in question are constructed with a metal neck positioned inside a metal stem. Due to metal corrosion and friction between the neck piece and stem, research strongly indicates – and FDA follow-up investigations seem to confirm – the device generates microscopic metal debris that is absorbed by surrounding bone and tissue. This can cause a deterioration in the joint’s support system and loosen the entire hip prosthetic, causing premature failure.

These extremely fine metal shards can also enter a patients’ bloodstream. This leads to several possible adverse reactions and other toxic reactions which – according to the FDA – may lead to:

  • Impaired kidney function
  • Thyroid problems, including weight gain, neck discomfort, fatigue and “phantom chills”
  • Depression, impairment of cognitive function or other psychological issues
  • Skin rashes
  • Impaired hearing or vision
  • Cardiomyopathy – a condition that weakens and enlarges the heart muscle

The only way to effectively reverse Stryker hip implant failure is surgical removal and replacement. The follow up procedure, however, entails its own risks:

  • Infection
  • Bone fracture
  • Increased risk of hip dislocation
  • Differing leg lengths
  • Pain
  • Additional rehabilitation

A Stryker Hip Replacement Lawyer Can Help

If you suffer from metal poisoning or other injuries from a defective Stryker hip implant, talk to your surgeon now. Get copies of your medical records, which will include the product labels of the system used in your hip replacement surgery. If you have a recalled implant, you need to speak with an experienced lawyer at your earliest opportunity.

The statute of limitations does apply, so you should speak with an attorney as soon as possible to ensure that your rights are protected and that Stryker is help responsible for its dangerous and defective products. This is important not only for your own needs, but for the needs of all patients who reply upon the manufacturers of medical devices to provide safe, effective mechanisms and treatment.

As we said above, Price Benowitz LLP does not handle Stryker hip replacement cases, but we can help you find an attorney who does.