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Source: www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4181b1_03_SSED_BHR_080505.pdf.

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

PREMARKET APPROVAL APPLICATION P040033 

SMITH & NEPHEW BHR  

BIRMINGHAM HIP RESURFACING SYSTEM

Download the original file here: SUMMARY OF SAFETY AND EFFECTIVENESS DATA 2005-4181b1_03_SSED_BHR_080505

Excerpts from the document:

2.0 INDICATION 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.

BHR System hip resurfacing arthroplasty is intended for joint replacement in patients who are at risk of requiring future, ipsilateral hip joint revision. While it is impossible to predict if a patient will require more than one joint replacement, several factors are known to increase risk of revision surgery including age less than 55 years at index surgery and/or high physical activity level postoperative.

5.0 POTENTIALADVERSE EFFECTS OF THE DEVICE ON HEALTH

The following adverse effects may occur in association with most any artificial 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,
  • Infection,
  • Temporary or permanent nerve damage resulting 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, complications may lead to death.

 

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