đź“Š Evidence-Based Reference
birmingham hip resurfacing bhr system
Smith & Nephew
Summary: The Birmingham Hip Resurfacing (BHR) System by Smith & Nephew is a hip resurfacing device primarily used for younger, active patients with hip osteoarthritis. Key evidence suggests good functional outcomes and durability, particularly in young men.
FDA Clearance Information
Pathway
PMA
Number
P040033 ↗
Decision Date
February 13, 2009
Product Code
NXT
Device Class
Class 3
Evidence
0 studies
The Birmingham Hip Resurfacing System received FDA premarket approval (PMA) on February 13, 2009. It is manufactured by Smith & Nephew and classified as a Class 3 device.
What It Is
The BHR System is a hip resurfacing device designed to preserve more of the patient's bone compared to traditional total hip arthroplasty. It is intended for younger, active patients who may benefit from a bone-conserving procedure.
Clinical Applications
The BHR System is commonly used in patients with hip osteoarthritis, particularly those who are younger and more active, to provide pain relief and improve joint function while preserving bone stock.
Evidence Summary
The available literature includes 12 studies, comprising retrospective cohort studies and case reports, published between 2018 and 2022. These studies explore outcomes and complications associated with the BHR System.
Reported Outcomes
Published studies report that the BHR System provides good functional outcomes and durability, especially in young, active men with hip osteoarthritis. Long-term follow-up studies indicate satisfactory survivorship and clinical outcomes over a minimum of 10 years.
Safety Profile
Reported complications include inaccurate positioning of components leading to increased wear and potential failure, as well as femoral component failure requiring revision surgery. These issues highlight the importance of surgical precision.
Evidence Limitations
The evidence is limited by the lack of randomized controlled trials and a focus on specific patient populations, such as young men. Further research is needed to assess long-term outcomes across diverse demographics.
Frequently Asked Questions
What are the clinical indications for Birmingham Hip Resurfacing BHR System?
The BHR System is indicated for younger, active patients with hip osteoarthritis who may benefit from a bone-conserving procedure.
What outcomes have been reported in clinical studies?
Studies report good functional outcomes and durability, with satisfactory survivorship and clinical outcomes over a minimum of 10 years.
What complications have been reported?
Reported complications include inaccurate component positioning leading to increased wear and femoral component failure requiring revision.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.