Medical Device Manufacturers should be Held Accountable if Their Devices Fail and Cause Injuries

Feb 23

There are three bones that make up the shoulder:

  • the shoulder blade or scapula;
  • the upper arm bone or the humerus; and,
  • the collarbone or the clavicle

A capsule, called the rotator cuff, which connects the upper arm bone to the shoulder blade, keeps the humeral head (also called the ball) on the glenoid (or the socket) and makes it possible for the arm to be raised and rotated. This humeral head and glenoid are what make up the shoulder joint.

Covering the ends of bones (where joints are formed) is a smooth and rubbery white tissue, called the Articular cartilage. Besides cushioning the bones of the joints, this cartilage also enables the joints to move with ease and reduces the friction when bones glide over each other. Though tough and flexible, the Articular cartilage can break down or get damaged quite easily. When this happens, the result is shoulder arthritis. The symptoms of shoulder arthritis include inflammation, shoulder stiffness and decreased motion, abnormal bone formation, and pain.

One popular corrective solution for those suffering from extreme joint pain or a limited range of shoulder motion is shoulder replacement surgery, which doctors recommend, but only if all non-surgical forms of treatment fail. This surgery involves the removal and replacement of damaged parts of the shoulder. In replacing damaged parts, an artificial device, known as prosthesis, is used. Though artificial, this implant is designed to offer relief by reducing or removing pain and restoring shoulder strength, function and motion. These are the expected results of a shoulder replacement surgery, unless something else than what should be, happens, like implanting in patients a faulty replacement device. The result of this would be increased pain, additional costly medical expenses and probably the necessity for a corrective surgery plus the removal of the implanted device.

On August 25, 2008, pharmaceutical company Zimmer Biomet manufactured a device called the Comprehensive Reverse Shoulder System Humeral Tray. This surgically implanted shoulder replacement device is intended to help restore arm movement. This device would benefit those with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy, as well as those with previously failed shoulder joint replacement.

Zimmer Biomet, according to the U.S. Food and Drug Administration (FDA), however, had to recall this Comprehensive Reverse Shoulder replacement device because these are said to be fracturing at a higher rate than is stated in its labeling. Zimmer shoulder implant fracture may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection or death.

As explained by the law firm Williams Kherkher, medical device manufacturers have a responsibility to properly test and label their devices, and if those systems fail, they should be held accountable for the injuries they cause.

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