Smith & Nephew R3 Recall
The Smith & Nephew Reflection 3 (R3) Acetabular Hip was approved via the Food and Drug Administration (FDA) 510k process in 2007. Smith & Nephew Orthopaedics issued a recall for metal liners of the R3 acetabular system on June 1, 2012. The use of Smith & Nephew R3 in total hip replacements is associated with a higher than expected number of revision surgeries, prompting a market withdrawal of the devices.
The metal-on-metal liner is linked to various health issues including but not limited to:
- metal sensitivity
- difficulty walking and pain
Smith & Nephew recommends physicians maintain their typical follow-up protocol for patients who have undergone total hip replacement or resurfacing surgery and implanted with the Smith & Nephew R3. However, this advice can have adverse long-term consequences, both physically and financially. You should immediately have your blood tested for cobalt and chromium whether or not you have pain, and/or swelling or other unexplained symptoms. Patients with cobalt and chromium levels above 0.3 micrograms per liter (mg/l) or parts per billion (ppb) require monitoring since these levels are abnormal.
You may be entitled to compensatory damages including:
- lost wages
- medical expenses
- cost of disability
- property loss or repair
- pain and suffering
- loss of consortium (if applicable)