Birmingham Hip Resurfacing - Literature Review

A complete list of the complications and adverse events identified in the case series review is provided in Summary of Clinical Studies, Table 14.

Potential Adverse Effects
The following adverse effects may occur in association with hip replacement surgery including the BHR System:
• Cardiovascular complications including venous thrombosis, pulmonary embolism, or myocardial infarction.
• Sudden, pronounced, intraoperative blood pressure decrease due to the use of bone cement.
• Hematoma or damage to blood vessels resulting in large blood loss.
• Delayed wound healing.
• Superficial or deep infection. Infections may occur months to years after surgery and these infections are difficult to treat and may require reoperation with removal surgery and later replacement at another time.
• Temporary or permanent nerve damage resulting in functional and/or sensory deficits in the affected limb.
• Metal sensitivity reactions or allergic reactions or metallosis.
• Dislocation or subluxation leading to post-operative joint instability (which may be caused by malpositioning of the implants, or muscle or fibrous tissue laxity).
• Component loosening or migration due to trauma, loss of fixation, malalignment, or bone resorption.• Limb length discrepancy.
• Increased hip pain and/or reduced hip function.
• Fatigue fracture of the implants as a result of excessive loading, malalignment, or trauma.
• Osteolysis and/or other peri-prosthetic bone loss.
• Unintended bone perforation or fracture occurring either intra-operatively or post-operatively as a result of trauma, excessive loading, osteolysis, or osteoporosis.
• Periarticular calcification or ossification.
•Wear or deformation of the articular surface as a result of excessive loading or implant malalignment.

Any of these adverse effects may require medical or surgical intervention. Rarely, these adverse effects may lead to death.
 

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2/4/2007

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