The BIRMINGHAM HIP™ Resurfacing (BHR™) prosthesis is a metal-on-metal hip resurfacing prosthesis. The device consists of a stemmed femoral head resurfacing component designed for cemented fixation, and a hemispherical acetabular cup designed for cementless, press-fit, fixation. The acetabular cups are configured in one-piece designs. Instrumentation sets are provided as standard; several additional instruments are available as options.
Indications for Use
The BIRMINGHAM HIP Resurfacing (BHR) System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to:
• Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
• Inflammatory arthritis such as rheumatoid arthritis.
The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.
• Patients who are female
• Patients with bone stock inadequate to support the device including:
– Patients with severe osteopenia or patients with a family history of severe osteoporosis or severe osteopenia.
– Patients with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade).
– Patients with multiple cysts of the femoral head (>1cm).
– Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess bone stock status.
– Patients with known moderate to severe renal insufficiency
– Patients who are immunosuppressed with diseases such as AIDS or persons receiving high doses of corticosteroids
– Patients who are severely overweight
– Patients with known or suspected metal sensitivity (e.g., jewellery)
Warnings and Precautions
U.S. Federal law restricts this device to sale by or on the order of a physician.
• Patients who, from plain radiograph pre-operative templating, appear to require 48mm femoral heads should not be considered as candidates for BHR implantation. Patients requiring a 48mm femoral head size are at a moderately elevated risk of requiring revision surgery earlier than expected. While Smith & Nephew concluded that the increased risk associated with this head size does not outweigh the potential benefit to the patient in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measurement of 48mm at the time of surgery, surgeons should use their best medical judgment to consider this information relative to the patient’s overall medical history and prognosis in determining its appropriateness as a surgical treatment.
• Patients on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in systemic metal ion concentration. Preoperative and postoperative monitoring of renal function (such creatinine, GFR, BUN) will be necessary for these patients.
• Only physicians who have received appropriate training and are familiar with the implant components, instruments, procedure, clinical applications, adverse events, and risks associated with the BHR System should use this device. Contact Smith & Nephew, Inc. for the surgical technique manual and procedural training protocol.
• Currently, Smith & Nephew, Inc. does not have a commercially available metal femoral head and stem (monoblock or modular) for use with a BHR resurfacing cup. Therefore, if the BHR resurfacing head must be revised to a total hip arthroplasty, the BHR acetabular cup must also be revised, even if well fixed.
• Based on literature reports together with the manufacturer’s post-market data, the following were identified as risk factors for early revision:
– Patients who receive a 48mm femoral head;
– Patients who receive a device which is incorrectly positioned;
– Patients who have a diagnosis of avascular necrosis;
– Patients who have congenital dysplasia; and
– Patients who are obese.
The more risk factors a patient has, the greater the risk of procedure failure requiring a revision of the hip.
To review the information needed to understand and use this product safely and effectively, including product risk information and surgical technique, please consult the product's Instructions for Use (IFU).
Smith & Nephew, Inc.
1450 Brooks Road
Memphis, TN 38116 USA
+1 800 238 7538 US Customer Service
Smith & Nephew Orthopaedics Ltd
Spa Park, Harrison Way, Leamington Spa
Warwickshire, CV31 3HL, UK
+44 (0)845 056 8333 UK Customer Service