What is a constrained component?
Constrained components usually include a locking mechanism incorporated into the polyethylene acetabular liner to keep the prosthetic femoral head in place. Two different prosthetic designs are available and have been approved by the U.S. Food and Drug Administration.
How do constrained liners work?
An external metal ring is locked to the liner to prevent it from re-expanding (Fig. 1). An example of a constrained system using an external metal ring locked to the liner in order to avoid mechanical re-expansion of the liner once the head is within the socket.
What is the most durable hip replacement?
Ceramic head implants are designed to be the most resistant to wear. Early designs had the risk of breaking. The newer designs are much stronger and it is almost unheard of to have the newer ceramic femoral heads break. Ceramic heads are very hard and very smooth.
Can your body reject a prosthetic hip?
Once your hip is taken out, there is no putting it back. So, if your body rejects the implant, you will have major issues. Because of the numerous problems associated with hip replacements, it is crucial that patients are aware of and understand the risks before making the decision to have hip surgery.
What is a constrained total hip?
Constrained acetabular liners are a powerful revision option for achieving joint stability particularly when the cause of dislocation cannot be determined. They are designed to hold the femoral head captive via a secure locking mechanism.
What is constrained liner hip?
What is the liner in a hip replacement?
The outer ball is made of plastic (highly cross-linked polyethylene). The acetabular liner fits into the cup and serves as your new “cartilage”. Much like the cartilage in your hip, it is susceptible to wear and historically this has been the “weak link” of total hip replacement.
What is a polymer constrained cemented prosthesis?
A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together.
What is a hip joint prosthesis?
The hip joint metal/polymer constrained cemented or uncemented prosthesis is intended to replace a hip joint.
Does the constrained liner prevent hip instability?
The constrained liner prevented instability in 54 of 56 hips (96%) after an average followup of 3 years, which is a significant improvement over the traditional methods of achieving stability. Goetz et al 12 also used the constrained liner in situations of neuromuscular deficiency and intraoperative instability, implanting 101 liners.
Are there any risks in using a hip prosthesis?
Risks to Health FDA has identified the risks to health generally associated with the use of the hip joint metal/polymer constrained cemented or uncemented prosthesis in the table below. You should also conduct a risk analysis, prior to submitting your 510 (k), to identify any other risks specific to your device.