Did You Suffer Injury from a Shoulder Replacement Device?
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Shoulder replacement surgery may be the recommended course of action by a doctor for a patient who has suffered an injury to some part of their shoulder. It may be a rotator cuff injury or a fracture of the humerus. More patients are receiving shoulder replacements for rheumatoid arthritis and other chronic conditions as well. It can be beneficial for people who have severe pain or limited mobility in their shoulder. The surgery may be done on one or both sides, depending on the location of the injury or pain.
While not as common as hip and knee replacement surgeries, shoulder replacement is becoming a more normal practice. According to the Agency for Healthcare Research and Quality, there are about 53,000 shoulder replacement surgeries in the US each year as compared to the 900,000 knee and hip replacement surgeries.
Risks and Complications of Shoulder Replacement Surgery
While shoulder replacement surgery has grown in popularity, there are still several risks associated with this procedure. Some of the most common include the following:
- Infection – may occur around the prosthesis or directly in the wound; may occur right after surgery or even years later. Treatment for a severe infection may include removal of the prosthesis.
- Wearing of the prosthesis – over time, the components of the prosthesis may loosen and wear down, causing them to become dislocated
- Nerve injury – nerves surrounding the joint replacement may be damaged during surgery
Reverse shoulder replacements have their own unique set of issues. While this type of surgery has benefited many patients, it has also led to complications, such as:
- Periprosthetic fracture – fracture of the bone, which surrounds the implant
- Hematoma – blood trapped in the joint
- Neurologic injury – the nerves are pulled or cut during surgery, leading to loss of feeling in the arm, hand or fingers
A Normal Shoulder
Three bones are connected to form your shoulder:
- Upper arm bone or humerus
- Shoulder blade or scapula
- Collarbone or clavicle
The humerus fits into the socket of your scapula, which is known as the glenoid. All of these bones work together to give your shoulder its range of motion. Cartilage lies between the bones where they join to allow them to move smoothly. A type of thin tissue, known as synovial membrane, covers the rest of the bones around the shoulder joint. It creates enough fluid to act as a lubricant and prevent friction. There are also muscles and tendons in the shoulder, which provide support for the bones.
The design of the shoulder allows it to have more mobility and a greater range of motion than other joints. The shoulder is also more susceptible to injury and other chronic conditions, especially as you age.
Reasons for Shoulder Replacement Surgery
Multiple conditions could create the need for shoulder replacement surgery over time. They include the following:
- Osteoarthritis – the cartilage gets soft and wears away from years of use, allowing the bones to rub together; most commonly seen in people over the age of 50
- Rheumatoid arthritis – inflammation of the membrane which leads to damage to the cartilage
- Post-traumatic arthritis – this type of arthritis can occur at any age and follows an injury to the shoulder such as a fracture or tear
- Rotator cuff tear arthropathy – caused by a long-term tear of the rotator cuff which leads to damage to the cartilage
- Avascular necrosis – certain injuries, illnesses and activities can cause the blood supply to the bones in the shoulder to be disrupted, resulting in the death of bone cells
- Severe fractures – some fractures cause a shattering of the humerus, which prevents it from being put back together again
Not everyone needs shoulder replacement surgery. It’s often recommended after the doctor has tried other treatments with limited success. People with any one of these conditions are a more likely candidate for this type of surgery.
What Happens with Shoulder Replacement Surgery
Only the damaged portion of the shoulder is removed in shoulder replacement surgery. These parts are replaced with a prosthesis which is an artificial device designed to mimic the natural shoulder. The surgeon may replace just the ball or head of the humerus or both the ball and the glenoid, also known as the socket.
With a total shoulder replacement, the surgeon will place a metal ball at the end of the arm bone, which will be attached to a stem. A plastic socket will be inserted to allow for movement. If the bone is soft around the replacement location, the prosthesis may need to be cemented into place. If the bone is still in good shape and solid, they may opt for a press fit instead.
Another option is known as stemmed hemiarthroplasty, which includes replacement of just the ball. This procedure is often done when the head of the humerus has been seriously fractured but the socket is still intact. A third option is the resurfacing hemiarthroplasty, which uses a cap prosthesis with no need for a stem. This surgery is often recommended for those with arthritis or an old injury.
A reverse shoulder replacement surgery may be recommended if another shoulder replacement surgery failed or for those with severe tearing of the rotator cuff or arthritis or those with severe arm weakness from a complete tear of the rotator cuff. In this procedure, a metal ball and plastic socket are attached, but in opposite locations. The ball is attached to the shoulder bone instead of the arm bone and the socket is located at the end of the arm bone. The result for the patient is they will now use the deltoid muscle to lift the arm instead of the rotator cuff.
Shoulder Replacement Revision Surgery
In some cases, shoulder replacement surgery doesn’t work for the patient. A second surgery may be required, called a revision surgery. This situation is most often seen when there has been infection in the shoulder, a dislocation, or if the implants were loosened.
If the revision surgery is being done to deal with failure of the implants, multiple surgeries may be necessary. The old components will need to be removed and corrective surgery may be required to prepare the shoulder for another surgery which will put in a new device.
Safety of Shoulder Replacement Prosthetics
Studies have shown that devices which use short stems and even those which are stemless are best suited for most replacement surgeries today. You can find these devices from several manufacturers, including Arthrex, Biomet and Zimmer. Safety has not yet been established with these devices because they are new.
Some of these manufacturers have been involved in lawsuits over the safety of their devices. One of the recent situations involves Zimmer-Biomet with its Comprehensive Reverse Shoulder Humeral Tray. The device was recalled because it had a higher risk for failure. The Food and Drug Administration (FDA) gave the recall a classification of Class I, which is the most serious kind of recall. As defined in the classification, there is a reasonable probability that the device would fail and cause serious health issues, including death.
With this device, research showed that patients were at a higher risk of infection and loss of shoulder function which would be permanent. In some cases, death was even a possibility.
This is not the first or only recall of shoulder replacement components. Another example was with Tournier in 2008 when certain products were recalled through a Class II recall. Biomet has also been involved in lawsuits over its products, in which plaintiffs claim they were injured by the device.
If you have had a shoulder replacement surgery that has led to complications and even the need for shoulder replacement revision surgery, you may be entitled to compensation. Some of these devices fail earlier than expected, lead to infection or cause other adverse effects. These effects include dislocation of the device, loosening of the components, infection, erosion and overall instability of the device. The result is injury to the patient who may require additional surgery to remove the device and other corrective procedures, including a replacement device.
What We Can Do
Our firm believes that every prosthetic manufacturer should be held responsible for the quality of their products. If a product does not perform as expected or leads to complications, the patient has a right to compensation for their expenses and suffering. More people are filing lawsuits to hold these manufacturers accountable. If you have suffered injury from a shoulder replacement prosthesis, you may be entitled to compensation for some or all of the following:
- Past medical expenses as well as any future costs of care
- Lost wages and the capacity to earn an income in the future
- Disability and disfigurement
- Pain and suffering, which may include emotional distress
If you have shoulder replacement surgery and now require a revision surgery or have significant bone loss, you may be entitled to compensation. Call us today and tell us about your situation. We will fight for your rights and hold the manufacturer responsible for the failure of their devices.