There are a number of defective medical devices that have caused serious injuries for patients nationwide. However, one company is under fire for creating several different hip replacement devices that place recipients at risk of debilitating side effects.
Zimmer Holdings Inc. has a documented history of releasing flawed hip replacement implants onto the U.S. market. Two of its products, the Zimmer M/L Taper Prosthesis and the Zimmer Durom Acetabular Component, have been linked to health problems and the need for additional surgeries in some patients. If you have received one of these devices, call the McGartland Law Firm to see if you have a case for compensation.
FDA Warning About the Zimmer M/L Taper Prosthesis With Kinectiv Technology
The Zimmer Kinectiv Prosthesis was marketed as a way for surgeons to custom fit the hip implant to the patient’s anatomy. Surgeons can remove damaged portions of the hip joint and replace them with Zimmer’s integrated hip system, including an artificial femoral stem and neck. But in the years after the device was approved by the FDA, the department began receiving reports of corrosion between the neck and stem, causing harmful side effects.
The corrosion was only one problem caused by the device. In 2015, the FDA issued a Class I recall due to higher than expected levels of manufacturing residues in the Zimmer M/L Taper. Failure to monitor the manufacture of the implants led to industrial residues left on the implant, which were then inserted into patients. As a result, patients who received the implant have suffered:
- Allergic reactions. Reaction to the residues varies from patient to patient, but may result in allergic responses, pain, inflammation, and metal poisoning due to debris and microscopic metal particles in the bloodstream.
- Inflammation and infection. Patients have experienced redness, tenderness, and swelling in the hip joint, as well as infection of the bone and tissues surrounding the implant.
- Loosening and dislocation. As the device began to wear against the bone surfaces, some patients experienced loosening of the replacement and joint dislocation that led to revision surgeries.
- Bone fractures. Many patients, especially post-menopausal women, suffered fractures in their hip bones due to defects in the neck and stem components.
- Bone and tissue loss. Patients who were forced to undergo revision surgeries to replace the device also suffered bone and tissue loss in the joint due to the nature of the Zimmer M/L Taper system.
Zimmer Pays Millions in Durom Cup Hip Injury Lawsuits
Zimmer’s Kinectiv device came just a few years after its Durom Acetabular Component, also called the Durom Cup, caused issues for thousands of patients. The Durom Cup was constructed from a single sheet of alloy metal that was supposed to fuse with the bone and stay in place without bone cement. Unfortunately, some patients found that the device failed to bond with the bone, causing pain, nerve damage, dislocation, and the need for revision surgery as early as two years from the original implantation.
Although Zimmer Holdings Inc. voluntarily suspended sales of its Durom Cup device in 2008, it reintroduced the product shortly afterward despite growing reports of injury. Zimmer has already paid nearly $400 million in settlements to patients who required revision surgery after receiving the Durom Cup, and many cases are still pending litigation in court. Cases have been filed against Zimmer at both the state and federal levels, and claims against the company include:
- Failure to warn of known risks of a harmful device
- Failure to properly test the Durom Cup before releasing it onto the U.S. market
- Misleading marketing and promotion of a medical device
- Releasing inaccurate information about the hip replacement’s safety and effectiveness
- Unfairly profiting from sales of a device that had known consumer dangers