Hip replacement parts made by Zimmer were recently recalled because of serious adverse effects in patients. The company™s femoral stems and necks were defectively made so that excess metals can infect patient™s blood, bone and nearby tissue after implantation. Hip implant lawyers at Pintas & Mullins Law Firm report on this recall below.
The recalled products™ official name is the Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks. These parts are made from a specific metal alloy blend called Tivanium, which is titanium enriched with nitrogen. Tivanium is supposed to have minimal particulate release, making it safe even for patients who are extraordinarily metal-sensitive.
Many patients have true metal allergies, which can present serious problems when they require hip or knee implants. According to a paper by a Seattle joint surgeon, patients receiving Tivanium implants perform quite well and do not have issues with metal sensitivity.
In early May 2015, Zimmer found process monitoring failures in its Tivanium hip implant manufacturing. These failures caused high amounts of metal residue on the implants, which can leak out into patients, resulting in various side effects, such as:
- Device failure and forced revision surgery
- Allergic reactions, or metallosis
On May 18, 2015 Zimmer issued recall notices to hospitals, instructing them to locate all recalled necks and stems and immediately return them. Surgeons who already implanted these products must be notified so they can contact their patients. This is considered a Class I recall, which are the most serious type involving situations where there is a reasonable likelihood that the products will cause serious side effects or death.
A full list of the recalled products can be found here, on the FDA website.
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Zimmer makes many types of hip replacement products, its most troublesome being the Durom Acetabular Component, commonly known as the Durom Cup. This product is made from cobalt-chromium metal and was meant to last longer and provide better range of motion than previous hip devices.
Unfortunately, this was not the case. The Durom Cups easily slipped out of place, causing patients excruciating pain and forcing patients to undergo painful and expensive revision surgeries. Zimmer recalled the Durom Cup in July 2008 because the surgical instructions were inadequate. Doctors blamed the Cup™s poor design and construction.
Zimmer reintroduced the Durom Cup after updating its labels and creating an online training program for surgeons. Injury lawsuits against Zimmer continue to mount, however, for the pain and massive medical bills patients suffered from these defective hip implants. The company created a $69 million fund to pay these Durom Cup claims, though there are many other Zimmer hip device products subject to injury lawsuits.
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The hip is the body™s largest ball-and-socket joint; as we age, the hip joints become less able to protect bones from normal wear-and tear and can lead to degenerative joint diseases. These conditions often cause chronic pain, joint stiffness and limited range-of-motion, which may require surgery. Many companies make hip implants, but the most severe injuries arise from metal-on-metal devices. More information on metal-on-metal hip implants and recalls can be found here.
Our team of hip implant lawyers is currently working on cases against companies like Zimmer that made defective, dangerous hip products. We are representing clients against companies like DePuy, Stryker, Biomet and Smith & Nephew to win compensation for medical bills, pain and suffering, and lost quality of life. Our case reviews are always completely free and available to injured patients nationwide.