In December 2015, an Arthrex knee replacement recall was issued after the device’s manufacturer found that it was incompatible with other models of the device due to a manufacturing irregularity.
The Arthrex knee replacement recall was issued on Dec. 17, 2015, and affected the Arthrex iBalance implant. The reason Arthrex gave for issuing the Arthrex knee replacement recall is that “Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.” While this sounds fairly innocuous, it essentially means that the product cannot be compatible with other components, which have a rough texture.
The medical device manufacturer officially announced its Arthrex knee replacement recall to distributors and medical facilities in February 2016, noting that the use of the devices should be discontinued.
According to the U.S. Food and Drug Administration, around 2,378 Arthrex iBalance units affected by the Arthrex knee replacement recall had made it into commerce, distributed across the U.S.
Patients who have reported problems with the Arthrex knee replacement device cite various complications which in some cases have required revision surgery to correct.
The Arthrex iBalance implant was created as a treatment for multi-compartmental knee cartilage degeneration, a condition often caused by osteoarthritis or post-traumatic arthrosis. The device was meant to offer another option for patients besides the traditional total knee replacement. Though the Arthrex iBalance implant was intended to reduce the need for further surgeries (knee replacements generally require additional surgery for metal plate and screw removal), complications of the Arthrex implant may lead many patients to undergo additional surgeries anyway.
Other Knee Replacement Recalls
The Arthrex knee replacement recall is not the only recall of its kind. Other knee replacement devices have recently been hit with similar recalls due to serious side effects that, in some cases, required revision surgery. Of course, revision surgery itself brings on its own risks of complications and infection, as well as further medical expenses.
The DePuy Synthes Attune knee system has reportedly led to device failure from several problems, including failure of components to bond, worn components, fracture, metal debris shedding, and loss of the bone’s attachment with the implant (osseointegration). A recall of the DePuy Attune Knee Tibial Articulation Surface Instruments was issued in June 2015 by the FDA.
The Exatech Optetrak knee replacement has also been linked with device failure, and patients have reported constant pain, implant loosening, and required revision surgery.
Filing a Lawsuit After the Arthrex Knee Replacement Recall
If you or someone you love has suffered from knee replacement surgery complications due to DePuy, Arthrex, or Exactech knee implants, you may be able to file a lawsuit. While filing a lawsuit cannot take away the pain and suffering caused by side effects of defective knee implant devices, it can help to alleviate the financial burden caused by medical expenses and lost wages.
Get a Free Knee Replacement Case Review
If you or a loved one suffered from complications caused by an Attune knee implant, an Arthrex knee implant, or an Exactech knee implant, you may have a legal claim. In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions. Get help now by filling out the form on this page for a FREE case evaluation.
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