Zimmer Natural Knee and Natural Hip
Hip and Knee Attorneys are currently reviewing Zimmer Natural Knee and Zimmer Natural Hip complaints. A number of patients implanted with the Zimmer Natural knee or hip or the Zimmer Natural Knee II have experienced complications and some patients may be facing revision surgery.
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Zimmer Natural Knee and Hip
Zimmer hip and knee attorneys believe that the Zimmer Natural is another defective medical device manufactured by Zimmer, and complaints from patients who have this type of hip or knee replacement implanted are similar to claims from patients who experienced problems with the Zimmer NexGen knee and the Zimmer Durom Cup hip replacement.
Currently, attorneys are seeing more problems with Zimmer Natural knees than hips. The Zimmer Natural knee is designed to be used with or without cement to give the patient a more natural range of motion and quicker recovery. However, recipients of the Natural knee have experienced anomalies in their healing and life expectancy of the implant.
On it website, Zimmer states that its Natural-Hip Family of stems has been successfully implanted in nearly 100,000 patients with over 12 years of outstanding long-term clinical results. It also shows the results of a clinical study that "yielded outstanding results", but patient data reveals that the clinical study comprised only 87 patients.
Zimmer Natural Knee Recall
In 2012 Zimmer' Natural-Knee II Durasul Patella product was issued a Class II recall for its knee replacement component due to reported device failures.
(The FDA describes a Class II recall as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.")
According to the FDA, "the pegs on the back side of the patella have sheared at the peg/patella interface". The Zimmer natural knee was also found to have lower fracture fatigue strength than other similar products. As of March 2012, the FDA reported 16 incidences where the patella peg sheared out.
Although a Class II indicates that a medical device is potentially dangerous, Zimmer Natural knee and hip devices are still on the market. The FDA has issued the following products Class II recalls:
- June 30, 2009, Natural Knee System Modular Cemented Tibial Baseplate: Tibial spacer will not affix to distal (outer) surface of the base plate, as intended.
- November 13, 2009, Gender Solutions Natural Knee Flex System: Surgeons may have difficulty inserting the polyethylene into tibial baseplate, resulting in damage to the device.
Patients with Zimmer Natural knee and hip replacements have reported similar symptoms as those with Zimmer' NexGen Total Knee Replacement devices, including:
- Breakage, mainly metal breaks from constant weight-bearing stress
- Fractures typically near the artificial joint
- Loosening of the attachment between the bone and artificial device, both in cemented and un-cemented artificial joints
- Painful stiffness and infection due to loosening of the attachment between device and bone
- Instability when the artificial joint dislocates
- Wear and tear on plastic parts
- Thrombophlebitis (blood clots in the legs)
- Myositis ossificans(calcium deposits in soft tissue around the knee joint, causing inflammation of muscles where they meet the bone)
- Loosening where a metal component or cement meets the bone
- Incision complications
- Bone fractures during surgery
- Dislocation of the new prothesis
- A difference in leg length because of the artificial knee
- More or faster loss of bone tissue
In 2010 Zimmer Holdings celebrated the 25th anniversary of its Zimmer Natural Knee System that has been used in about 400,000 implantations worldwide. Although Zimmer didn't report any adverse announcements from Zimmer Natural Knee or Hip replacement patients in its press release, attorneys have received many complaints that the Zimmer natural knee and hip device is allegedly defective.
Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer's 2009 sales were approximately $4.1 billion.
Zimmer Hip and Knee Recalls, Lawsuits and Settlements
Like its Durom Cup, the Zimmer NexGen has been named in complaints of high failure rates and complications. In 2010 several NexGen components were named in a Zimmer knee recall after it was determined the components were manufactured with defects or packaged with inadequate surgical instructions. In July 2011 the Zimmer NexGen Knee Lawsuits seek multi-district litigation (MDL) Consolidation. (Traditionally, MDL precedes multiple pre-trial mediations and non-disclosure settlements between plaintiffs and defendant drug companies.)
In 2010 Zimmer had put aside a settlement fund of approximately $145 million. (Also in 2010, Johnson and Johnson announced that it had put aside nearly $1 billion for expected liability payouts to patients who had received defective artificial DePuy hips.)
Zimmer Natural Claims
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