The Zimmer knee replacement devices have not been recalled, although a partial recall of a component of one of the devices was initiated. Plaintiffs who have filed lawsuits say they suffered personal injury and economic injury as a result of the knee device coming loose.
Further affecting Zimmer is a recent FDA Safety Communication (1/17/13) regarding metal-on-metal hip implants. That communication stated metal-on-metal hip implants have unique risks above and beyond those associated with all hip implants. The FDA noted that there is a risk of "adverse local tissue reaction" (ALTR) or "adverse reaction to metal debris (ARMD)," when metal particles wear off the hip implant and damage the bone and soft tissue in the nearby area. Damage to the soft tissue could cause pain and failure of the hip implant, requiring revision surgery. Furthermore, the FDA noted, metal ions could enter the bloodstream and cause harm in other parts of the patient's body.
When the FDA released its communication, it noted that doctors should only use a metal-on-metal hip implant if it is deemed to be more appropriate for a patient than other hip implant systems. Companies that manufacture metal-on-metal hip systems are conducting studies to determine the safety of their devices.
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Patients who undergo revision surgery could face long rehabilitation and costly medical bills.
Lawsuits filed against Zimmer allege its NexGen knee replacement device is defective, causing severe pain for patients who received the implant. Some lawsuits have been consolidated in multidistrict litigation in the US District Court for the Northern District of Illinois (MDL No. 2272). The MDL covers certain NexGen knee replacement devices, but not all.