Zimmer is the latest manufacturer of hip replacement devices to issue a recall of its products due to the risk of severe complications and health concerns. The M/L Taper Hip Prosthesis with Kinectiv Technology was designed to be a versatile option for use in minimally invasive surgical procedures.
Zimmer’s recall was the result of discovery that the products were linked to unhealthy levels of cobalt in the blood, resulting in metal toxicity and conditions such as metalosis. The recall was one of three Class One recalls mandated by the FDA affecting Zimmer, HeartWare and Maquet Holdings.
Metal Toxicity is a Common Concern for those Receiving Hip Replacements
The M/L Taper Hip Prosthesis is one of many artificial hip replacements that have caused health concerns due to cytotoxicity, which occurs when elevated levels of heavy metals enter the blood stream. What many of the devices that have been recalled have in common is that metal components in the devices are able to grind against each other, resulting in injuries when metal shavings enter the affected joint or the heavy metals in the devices reach the blood stream and are carried to the rest of the body.
Symptoms of metalosis— a form of metal toxicity— include the following.
- Infection of the affected joint which may spread to other areas of the body. When the infection reaches the bloodstream, it becomes what is referred to as sepsis, which is an advanced infection that can reach vital organs.
- Sudden changes in hearing or sight. Metal poisoning can impact the sense of sight or hearing and result in temporary or permanent vision and hearing loss.
- Tissue necrosis, which is defined most simply as the death of tissue surrounding the joint. This can result in damage to nerves and muscles that require corrective surgical procedures to address.
- Damage to the thyroid gland. The thyroid is primarily responsible for managing the body’s metabolism and metal toxicity can result in symptoms of thyroid problems which can include weight gain or loss and the development of goiters.
- Kidney disease or renal failure. Metalosis may adversely affect the kidneys resulting in infection or renal failure, in some cases requiring dialysis or a kidney transplant.
- Respiratory problems. Some patients suffering from metal toxicity experience breathlessness or difficulty breathing. Other respiratory diseases may follow, especially if the lungs become infected.
- Heart tremors, cardiomyopathy and heart failure. Toxic levels of metals such as chromium or cobalt can directly harm the heart or cause death due to sudden heart failure.
- Cognitive disorders. Those suffering from metalosis may find it difficult to concentrate, experience problems with memory, suffer from seizures or exhibit other symptoms of cognitive impairment.
- Severe pain at or near the site of the implant. If metal on metal parts produce metal shavings, this can cause great pain and discomfort that is exacerbated by the risk of infection and the pain that may accompany the other symptoms listed above.
- Death. Elevated levels of heavy metals are poisonous and if the metals accumulate over a significant period of time undetected, it could ultimately result in death due to metal poisoning or one of the other serious complications that are the result of metalosis.
Zimmer Named with Two Other Manufacturers in Recalls
In May of 2015, Zimmer sent an urgent medical device recall of 752 patients who received an M/L Taper Hip Prosthesis warning of the potential complications and providing instructions on how to respond to the recall. Existing devices are to be quarantined and Zimmer may ultimately pull the product from the market if it is determined that the current recall is not sufficient.
This recall comes as the FDA also issued Class One recall orders to Maquet Holdings and HeartWare, citing health serious concerns over their medical devices.
The number of medical device recalls has been continuing to rise at an alarming rate in recent history, making it even more important to put products through extensive trials and clinical research before allowing them to make it to market.
Zimmer’s recall is a symptom of a larger problem. There is a lack of oversight and too many avenues for medical device manufacturers to rush products to market before understanding the potential risk that patients will endure harm.
If you received a defective hip prosthesis and were injured as a result, contact the Rosenfeld Injury Lawyers LLC to learn more about current legal proceedings and how they might impact your own rights should you decide to pursue legal action.