Lawsuit alleges medical device to replace patient’s jaw had ‘inherent defects’

A medical device that was intended to replace a patient’s jaw had ‘inherent defects’ and caused increased pain, nerve damage and limited jaw movement, according to a statement of claim lodged in the county court of Victoria.

Celina (not her real name) had her right temporomandibular joint replaced with the OMX TMJ device in September 2017. The temporomandibular joint, known as the “TMJ”, connects the jaw to the skull, with one on each side of the head.

One year later, Celina also had her left TMJ replaced with the same device, the statement of claim filed to the county court in July says. The goal of both surgeries was to replace her damaged joints with a durable device that would restore jaw function and reduce joint pain.

Celina is now suing Maxoniq Pty Ltd, which manufactured the OMX TMJ device, in a case filed by Arnold Thomas & Becker. Celina alleges in her statement of claim that neither of the devices were fit for purpose. They were not durable, they were not free from defects and they were not as safe as would be expected by a reasonable consumer, it is alleged.

Celina, now aged 37, alleges that as a result of the OMX device allegedly not being of acceptable quality, the original surgeries to implant it and the surgeries required to address the device defects, she suffers more pain in her jaw and face, nerve damage, a speech impediment including a lisp and has limited range of motion when she opens her mouth.

“At the time of the first OMX joint surgery, the plaintiff was employed,” the statement of claim says. “She required time off work as a result of the poor results from the first and second OMX joint surgery and the revision surgeries. She makes a claim for past and future loss of earnings.”

Nytia Rajan, associate with Arnold Thomas & Becker, who is representing Celina, said it would be alleged that: “as a result of the treatment provided to our client, she has experienced a significant injury in the jaw and face, including nerve damage, limited opening of the mouth, and subsequently a speech impediment”.

Read the full story on The Guardian website.

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