What is bone cement and how it is used?

Patients’ medical conditions sometimes require the implantation of a medical device to replace damaged bone. One such device is an artificial knee.

Many surgeons use bone cement during total knee replacement surgeries. This may not be what you expect, however. “Bone cement” does not actually bond the bone and knee implant together. Rather, it fills the space between the knee implant and the patient’s remaining bone.[i]

Not all bone cements are created equal.

As one research paper explained, “[b]one cements may be divided into three kinds: low, medium and high viscosity.

     Low viscosity: these cements have a long-lasting liquid, or mixing phase, which makes for a short working phase. As a consequence, application of low viscosity cements requires strict adherence to application times.

     High viscosity: these cements have a short mixing phase and lose their stickiness quickly. This makes for a longer working phase, giving the surgeon more time for application.

Ideal viscosity will be high enough to avoid any cement mixing with blood or fat/bony material from the implantation region yet low enough to penetrate the bone adequately.”[ii] As such, research suggests that less than ideal viscosity can produce poor patient outcomes.

What are adverse events can occur with use of bone cement?

There are adverse reactions that can occur during surgery. Alternatively, the medical devices patients receive can cause injuries. Doctors, hospitals, and companies should report adverse events to the FDA. But, not all reports to the FDA have always been public. In addition to FDA’s adverse event data base, we rely on published articles.

The following problems with a knee implants involving bone cement have been reported as “[t]he most frequent adverse reactions reported with acrylic bone cements ….:

• Transitory fall in blood pressure.
• Elevated serum gamma-glutamyl-transpeptidase (GGTP) upto 10 days post-operation.
• Loosening or displacement of the prosthesis.
• Superficial or deep wound infection.
• Trochanteric bursitis.
• Short-term cardiac conduction irregularities.
• Heterotopic new bone formation.
• Trochanteric separation.”[iii]

In addition to the foregoing, Bone Cement Implantation Syndrome (“BCIS”) is another adverse outcome. BCIS is associated with clinical features including “hypoxia, hypotension, cardiac arrhythmias, increased pulmonary vascular resistance (PVR) and cardiac arrest. It is most commonly associated with, but is not restricted to, hip arthroplasty.” [iv] In addition, “[o]ne of the major drawbacks of bone cement in joint replacement is cement fragmentation and foreign body reaction to wear debris, resulting in prosthetic loosening and periprosthetic osteolysis.”[v]

Other potential adverse events include:

• “Hypoxaemia.
• Cardiac arrhythmia.
• Bronchospasm.
• Adverse tissue reaction.
• Haematuria
• Dysuria.
• Bladder fistula.
• Local neuropathy.
• Local vascular erosion and occlusion.
• Transitory worsening of pain due to heat released during polymerization.
• Delayed sciatic nerve entrapment due to extrusion of the bone cement beyond the region of its intended application.
• Intestinal obstruction because of adhesions and stricture of the ileum due to the heat released during cement polymerization.”[vi]

KBA’s investigation of bone cement lawsuits

The attorneys at KBA are investigating medical device cases involving patients who have experienced the following after have a knee implant failure:

• Instability and/or lack of balance
• Implant loosening (which may be described as “debonding” in the medical records)
• Unusual swelling at the joint site or surgical site (look around the incision)
• Decreased range of motion
• Weakness
• Persistent pain that continues long after surgery and despite therapy and treatment
• New chronic pain

Speak with your healthcare providers regarding concerns and contact KBA to investigate potential legal claims

Patients should understand that these are outliers and not things that always happen. Accordingly, do not avoid treatment based on this information. Speak with your doctors instead. Additionally, patients who have had these issues should remember that things besides bone cement can cause these issues. Patients expecting these problems should speak with their healthcare providers first and foremost. From a different perspective, the attorneys at KBA working with co-counsel can help investigate potential legal claims for damages related to medical devices.

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[i] Raju Vaishya, (MS, MCh, FRCS),^, Mayank Chauhan, (MS Orth), and Abhishek Vaish, (MBBS), J Clin Orthop Trauma. 2013 Dec; 4(4): 157–163.

[ii] Raju Vaishya, (MS, MCh, FRCS),^, Mayank Chauhan, (MS Orth), and Abhishek Vaish, (MBBS), J Clin Orthop Trauma. 2013 Dec; 4(4): 157–163.

[iii] Raju Vaishya, (MS, MCh, FRCS),^, Mayank Chauhan, (MS Orth), and Abhishek Vaish, (MBBS), J Clin Orthop Trauma. 2013 Dec; 4(4): 157–163.

[iv] Raju Vaishya, (MS, MCh, FRCS),^, Mayank Chauhan, (MS Orth), and Abhishek Vaish, (MBBS), J Clin Orthop Trauma. 2013 Dec; 4(4): 157–163 (citing Donaldson A., Thomson H., Harper N. Bone cement implantation syndrome. Br J Anaesth. 2009;102:12–22.)

[v] Raju Vaishya, (MS, MCh, FRCS),^, Mayank Chauhan, (MS Orth), and Abhishek Vaish, (MBBS), J Clin Orthop Trauma. 2013 Dec; 4(4): 157–163.

[vi] Raju Vaishya, (MS, MCh, FRCS),^, Mayank Chauhan, (MS Orth), and Abhishek Vaish, (MBBS), J Clin Orthop Trauma. 2013 Dec; 4(4): 157–163.