Stryker Recalls Metal Hip Products Due to Safety Concerns

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Stryker Recalls Metal Hip Products Due to Safety ConcernsOverview: Stryker Orthopaedics is voluntarily recalling their Rejuvenate Modular and ABG II modular-neck hip stems used in metal-on-metal hip implants. The decision was based on fears that the components contribute to corrosion, which could lead to adverse local tissue reaction.

 

 

  • Stryker is recalling two stems used in all-metal hips because of the potential for corrosion
  • Stryker also recalled the MITCH THR System with uncemented Accolade stem in April
  • Metal hips can release metal ions, which can contribute to a number of health problems

Product: Rejuvenate Modular and ABG II modular-neck hip stems

Manufacturer: Stryker Orthopaedics

Side Effects & Complications

  • High failure rate
  • Necrosis (tissue death)
  • Increased levels of cobalt and chromium ions
  • Pain at the implant, sometimes spreading to the groin and back
  • Osteolysis (bone loss)
  • Fluid collections/solid masses around the hip joint

Fear of Corrosion, Tissue Damage

Stryker-funded researchers say that modular neck stems were thought to offer better precision, and “provide the surgeon the unique advantage to more exactly reproduce or correct the patient’s anatomy and hip biomechanics.” It appears that the risk of corrosion, however, has dampened the devices’ safety profile. Stryker says that it “decided to voluntarily recall these modular-neck stem hip systems because there is a potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions.” The company advised patients with pain and/or swelling to speak to their surgeon.

Metal-on-Metal Hips Under Scrutiny

This is Stryker’s second metal hip-related recall this year. In April, the company recalled the MITCH THR modular head/acetabular cup in combination with the Accolade femoral stem.

Fears over metal hips rose quickly in August 2010, when DePuy issued a worldwide recall of its ASR products. Since then, studies have continued to link the devices to various side effects. For the most part, the implants are associated with exceptionally high failure rates. According to a study published in the Lancet in March, metal-on-metal hips failed in six percent of patients with all-metal hips as opposed 1.7 to 2.3 percent with plastic or ceramic hips; the authors concluded that metal hips should be banned altogether. The month prior, the British Medical Journal published a report scrutinizing the metal hip industry and regulators for exposing unknowing patients to serious risks.

Last week, the Food and Drug Administration’s (FDA’s) Orthopaedic and Rehabilitation Devices Panel reviewed metal-on-metal implants and recommended that patients undergo X-rays and other imaging techniques to detect abnormalities. The panel also advised stronger warnings for complications like pseudotumors and elevated metal ion levels.