FDA Issues New Hip Implant Guidelines

[caption id="attachment_1583" align="alignright" width="300"]Hip Implant Lawsuit Image Credit: FDA.gov[/caption] In 2010, DePuy Orthopedics spent approximately $800 million on the recall of a its hip implant device after patients sustained serious injury after use.  With an aging population, all-metal hip implants have become popular, promising increased mobility to patients with hip problems.  In fact, an estimated 500,000 Americans have received all-metal implants.  Unfortunately, many of those hip implants fail or deteriorate, causing significant pain and damage.  Recently revealed documents show that Johnson & Johnson knew that its DePuy Articular Surface Replacement (ASR) hip implant was likely to fail in approximately 40% of patients within five years, and that it was likely to fail prematurely in thousands more. Recalled hip implant devices include:

  • DePuy Orthopaedics ASR XL Acetabular System
  • DePuy Orthopaedics ASR Hip Resurfacing System
  • Biomet Mallory-Head
  • Exactech Metal liner of R3 Acetabular System
  • Exactech Opteon
  • Stryker Orthopaedics Rejuvenate and ABG II modular-neck hip stems
  • Stryker Orthopaedics Omnifit
  • Stryker Orthopaedics Sulzer Inter-Op acetabular shell
  • Wright Medical Technology Conserve Plus and Profemur Z Hip Stem
  • Zimmer Holdings Durom Acetabular Component (Durom Cup)
  • Zimmer Holdings Mayo Hip
The risk of injury from metal-on-metal hip replacement implants has prompted the Federal Food and Drug Administration (FDA) to issue new guidelines for the use of these medical devices. According to the FDA website: "All artificial hip implants carry risks including wear of the component material. Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants. In MoM hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device into the space around the implant. Wear and corrosion at the connection between the metal ball and taper of the stem may also occur. Some of the metal ions (e.g. cobalt and chromium) from the metal implant or from the metal particles will enter the bloodstream. Orthopaedic surgeons take several precautions before and during hip replacement surgery to try to optimize the way in which the ball and socket rub against each other so that fewer wear particles are produced. However, there is no way to fully avoid the production of some metal particles. Different people will react to these metal particles in different ways. At this time, it is not possible to predict who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. Over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).” Soft tissue damage may lead to pain, implant loosening, device failure, and the need for revision surgery (the old device is removed and replaced with another one). Patients with a progressing ALTR may be considered for earlier revision to prevent extensive damage to bone, muscle and nerves." Because of the concerns about metal-on-metal hip implants, the FDA recommends that surgeons only use all-metal implants when the benefits outweigh those of an alternative device.  Patients with pain, numbness, swelling, or a change in their ability to walk are advised to consult an orthopedic surgeon immediately; those without symptoms are cautioned to follow up with their physicians every one to two years. If a defective medical device has caused you pain and suffering, you may be able to receive compensation from the device manufacturers or other associated with the negligent use of the product.