Smith and Nephew PLC has recalled a metal liner used in its R3 Acetabular System after patients reported infections, fractures and dislocations. In issuing the recall, the company stated that it was not satisfied with the clinical results of the component, with one spokesman reporting that an uptick in revisionary surgeries prompted the action. Approximately 7700 patients have been implanted with hip implants using the now-recalled metal liners.
In light of this recall, our attorneys reviewed injury claims on behalf of patients who were implanted with the R3 Acetabular System using this metal liner. Potentially, these individuals may be able to seek compensation for medical bills, pain and suffering and other losses associated with their hip implant.
Hip Implants and Metallosis
A number of metal-on-metal hip implants have reportedly been linked to metallosis, a type of poisoning caused by the release of metal debris into the body. A spokeswoman for Smith and Nephew claimed that metallosis was not among the problems which necessitated the recall of the metal liner. It has been alleged that the company may have been too quick to discount metallosis as the cause of the patients’ injuries, as a number of metal-on-metal hip implants have been linked to this dangerous condition.
DePuy’s recalled ASR hips and several other devices have been linked to metallosis, which occurs when the metal components of the devices rub against each other, releasing metallic ions as they wear. The body can develop a severe inflammatory response to the debris, resulting in muscle and soft tissue damage. Metallosis is of particular concern because such damage can compromise revision surgery. In addition, extreme levels of cobalt can result in a number of problems, including but not limited to the following:
- Optic nerve damage
Eligibility for Lawsuit against Smith and Nephew
Faced with mounting concerns over the safety of metal-on-metal hip implants, the FDA announced in March 2012 that it would schedule a two-day review of the devices gathering input from scientists, doctors, patients and researchers to determine whether new standards should be issued for these types of hip implants. Johnson & Johnson’s DePuy Unit, Stryker Corp; and other metal-on-metal hip implant manufacturers have already been hit with thousands of lawsuits from patients who claim they suffered metallosis or other injuries from the devices.