Smith & Nephew PLC, has recalled a metal hip socket liner used with its R3 Acetabular System hip device. The device coupled with the optional metal liner creates an all-metal artificial hip system, which is used in stemmed total hip replacements. This recall follows similar recalls by manufacturers like Johnson & Johnson that has recalled Depuy metal-on-metal hip devices.
The metal liner was made available in 2009, and is estimated to have been implanted in 7,700 patients. Smith & Nephew’s voluntary recall of its metal liner comes after unsatisfactory clinical results and a market trend of faulty or dangerous metal-on-metal hip implants.
Smith & Nephew Not Satisfied With Clinical Results
The British company, Smith & Nephew PLC, says it is, “not satisfied with the clinical results” for its metal liner in the R3 Acetabular System hip device. Many recipients of the R3 Acetabular System hip device and the optional metal liner have needed the metal liner removed or a revision surgery on their hip replacement implant.
According to the British National Institute for Health and Clinical Excellence (NICE), which monitors the delivery of quality healthcare, the rate of revision among patients with the metal liner device is 1.6%. This is above the 1% acceptable rate set by the NICE.
Metal-On-Metal Hip Implants
With this voluntary recall, Smith & Nephew follows in the footsteps of other manufacturers of metal-on-metal hip replacement implants. In 2010, Johnson & Johnson recalled its DePuy metal-on-metal hip unit. Smith & Nephew claims there is no evidence of metallic debris in the body as a result of the grinding motion of its all-metal artificial hip system, like with its Johnson & Johnson counterpart, but Smith & Nephew admits there are incidents of other injuries such as fractures and infections.
As a general trend, metal-on-metal hip implants tend to cause more complications and require more revision surgeries than other types of hip replacement implants. The Food and Drug Administration (FDA) is considering stricter regulations on these types of devices. The FDA will hold a hearing June 27-28, 2012 to review the safety of metal-on-metal hip replacements which will include evaluating data on risk, failure rates and complications.
Due to the recall of the metal socket liner, Smith & Nephew’s R3 Acetabular System will now be paired with alternative non-metal liners.
If you or a loved one has a Smith & Nephew or other metal-on-metal hip, you should consult a metal-on-metal implant lawyer for a legal consultation.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.
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