Birmingham Hip Resurfacing - Literature Review

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. 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 modular metal femoral head for use with a BHR resurfacing shell. Therefore, if the BHR resurfacing head must be revised to a total hip arthroplasty, the acetabular shell should also be revised, even if well fixed.

Preoperative
Do NOT use any component of the BHR system with another manufacturer’s implant components, because designs and tolerances may be incompatible.

Do NOT use BHR system components (which are cobalt chrome) with any stainless steel components, since corrosion can occur between two dissimilar metals.

Previous hip surgery such as osteotomy, core decompression, hemiresurfacing, or internal fixation may increase the risk of early failure.

Examine instruments for wear or damage before use. While rare, intra-operative instrument breakage can occur. Instruments that have experienced excessive use or force may be susceptible to breakage.

Intraoperative
Implants should be accepted only if received by the hospital or surgeon with the factory packaging and labeling intact. If the sterile barrier has been broken, return the component to Smith & Nephew, Inc.

Avoid notching the femoral neck, as this may lead to femoral neck fracture.

Avoid placing the femoral component in varus. Varus placement of the femoral component has been associated with femoral neck fracture.

Do NOT re-use an implant. All implants are intended for single-use only.

Use the recommended instruments and the recommended surgical technique.

Improper selection, placement, positioning, and fixation of the implant components may result in early implant failure.

Malalignment of the components and/or soft tissue imbalance may cause excessive wear and early implant failure.

Associated trials and templates should be used for verification of component size. If an appropriate component size cannot be found during pre-operative planning, do not use this type of implant.

Complete pre-closure cleaning of the implant site (complete removal of bone chips, bone fragments, metallic debris, etc.) is critical to prevent wear of the articular surfaces.

Using instruments other than the associated BHR instruments may result in inaccurate placement.

Hydroxyapatite-Coated Acetabular Implants
Do NOT allow the HA-coated, porous-surfaced acetabular component to contact any substance other than the device packaging, clean gloves, or the patient’s tissue.

Do NOT use cement with these HA-coated, porous-surfaced implants.

Take care to achieve a stable press fit. The HA-coated, porous surface is not intended to compensate for inadequate implant fixation.

Postoperative
Excessive physical activity levels, excessive patient weight, and trauma to the joint replacement may cause early failure of the implant.

Loosening of components may increase production of wear particles and accelerate damage to the bone, making successful revision surgery more difficult.

Patient Education
Warn the patient of the surgical risks, possible adverse effects, and possible operative complications that can occur with joint arthroplasty.

Warn the patient of the limitations of artificial joint replacement devices.

Caution the patient to protect the joint replacement from unreasonable stresses and to follow the treating physician’s instructions. In particular, warn the patient to strictly avoid high impact activities such as running and jumping during the first post-operative year while the bone is healing.

Warn the patient that artificial joint replacement devices can wear out over time, and may require replacement.
 

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2/4/2007

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