Smith & Nephew has recalled the R3 metal liner, which is used with the R3 Acetabular Hip System. Studies indicate that at least 6% of the implants fail within four years. The problem is that the metal-on-metal design can shed toxic particles of metal into a patient’s body, which can cause pain, inflammation, metal poisoning, and other complications that require revision surgery.
What is the problem?
Smith & Nephew is the Australian manufacturer of the R3 Acetabular System, which is used exclusively with the Birmingham Hip Resurfacing System. The R3 is designed to accommodate interchangeable liners (metal, plastic, or ceramic).
The problem is that a metal-on-metal hip implant is created in patients who are given an R3 metal liner in combination with a metal femoral head. Although metal-on-metal hips were originally marketed as safer and longer-lasting than plastic and ceramic implants, experts warn that all-metal hip implants have additional risks and can fail sooner.
From 2009 – 2012, at least 4,000 Americans were implanted with the R3 Acetabular metal liners. Individuals who were implanted with this defective device may be eligible for legal recourse through a Smith & Nephew R3 hip implant lawsuit. Many lawsuits have already been filed, but they are not part of a class action. Instead, they are individual lawsuits filed by people who hired an attorney.
Smith & Nephew R3 Hip Implant Recall
Smith & Nephew and the U.S. Food and Drug Administration (FDA) announced a recall of the R3 metal liners on June 1, 2012 because the number of revisions surgeries was “higher than expected.” Australian health authorities also issued a recall with statistics on the failure-rate:
- The United Kingdom’s National Joint Registry, which shows a revision rate of 6.3% at 4 years (compared to 2.89% at 4 years for all primary total hip replacements in the UK).
- The Australian Orthopaedic Association’s NJRR which shows a revision rate of 2.48 revisions per 100 observation years (compared with a revision rate of 0.79 revisions per 100 observation years for all primary total hip replacements in Australia).
Complications of R3 Hip Implant
The metal liner of the R3 Acetabular System is made of chromium and cobalt. When parts of a metal-on-metal hip implant grind together, tiny particles of metal can shed into a patient’s hip joint. Chromium tends to form an irritating residue around the hip, which can cause pain, inflammation, and swelling. Cobalt ions are water-soluble and can leech into a patient’s bloodstream, causing systemic reactions like blood poisoning, metallosis, and genotoxicity.
R3 hip implant complications:
- Loose or dislocated hip implant
- Chronic pain
- Limited mobility
- Metal poisoning (metallosis)
- Soft-tissue growths (bursas, pseudo-tumors)
- Bone loss in the hip
- Revision surgery
- And more