There are two components that comprise this hip resurfacing device:
The Femoral Component - a part of the device that was partly made of metal and plastic in spherical form reshaping and capping the bone located at the top of the thigh with a small neck attached that is to be inserted into the femur bone.
Acetabular shell - a shallow cup that is used as a substitute for the injured socket of the hip.
The implant was designed in such a way that will allow both the spherical bone and cup pelvis socket to rub against each other.
In comparison to traditional hip replacement, the hip resurfacing system takes on a minimally invasive approach by recovering the hip ball and reconstructing its natural anatomy.
It was created to help people with injured hip bones caused by accident and those that have congenital defects that led to its dysfunction.
However, due to its unique nature and procedures as to which it is applied; hip resurfacing has its own risks that appear to be of greater frequency as compared to that of a traditional total hip replacement.
Hip resurfacing system presents risks that may come together with increased failure rate, femoral bone fracture and thinning of the bone's neck, avascular necrosis (dysfunction of the bone brought about by lack of enough blood supply), susceptibility to heterotopic ossification (growth of an unnecessary bone located around the hip causing rigidness and further disability), blood stream disseminated with a higher level of metal ions accumulated overtime, and allergy-like metallic reactions. In addition, its long-term results are yet to be discovered.
Despite having known the possible risks that the hip replacing system may pose, it has not deterred Wright Medical Technology from endorsing their product as safe and effective.
Having gone through pre-market notification, the Conserve Plus Hip Resurfacing System successfully acquired clearance through the FDA 510 (k) process (a device approval process that grants the permission for a medical device to be distributed into the market once proven to be "substantially equivalent" as safe and effective as another lawfully marketed device designed for the same usage), and was made available to the market.
Being FDA 510 (k) approved, the Wright Conserve Plus is made eligible to the market and patients without having to go through a series of appropriate trials to confirm its safety and effectiveness.
The process' capability of ensuring safety and effectiveness has been considered as a loophole concerning some medical experts. The Safety of Untested and New Devices Act of 2012 is working on having numerous processes regulated including the FDA premarket notification, 510 (k).
URL References:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm191091.htm
http://www.ganapathihipkneesurgeon.com/hip%20resurfacing.html
