An Arthrex tibial tray recall was issued in March 2016, after the company discovered a problem with the knee implant.
According to the Arthrex tibial tray recall, the outer part of the knee implant had a smooth texture that made it incompatible with other components with a rough texture.
This incompatibility ultimately spurred the company to issue the Arthrex tibial tray recall.
The Arthrex tibial tray is a component of the Arthrex iBalance Total Knee Arthroplasty (TKA) system, which was designed to restore knee joints that were seriously damaged by disease or injury.
Arthrex specifically designed the iBalance TKA knee implant to help treat multi compartmentalized knee cartilage deterioration caused by degenerative arthritis or traumatic arthrosis.
Arthrex marketed the iBalance TKA as an alternative to total knee replacement implants, with the company designing the product to reduce the need for revision surgery.
Typical knee replacement surgery involves using plastic or metal caps placed on the end of the bones, to form the knee joint and kneecap. Comparatively, the iBalance TKA was meant to prevent further cartilage damage and reduces the need for revision surgery that is often required for the prosthetics.
The iBalance TKA was approved through the FDA’s 510(k) process, which allows a medical device to be released into the market without the same preclinical testing as fully new devices. According to Arthrex marketing statements, the iBalance TKA knee implant is “a novel and innovative instrument platform that facilitates an accurate, efficient, and reproducible surgical technique.”
Overview of Arthrex Tibial Plate Concerns
However, patients have allegedly been experiencing knee replacement complications soon after implantation.
The company announced the nationwide Arthrex tibial tray recall after the company made the discovery about the differing tibial tray surfaces between earlier and later models. Arthex reportedly sent Urgent Medical Device Voluntary Recall letters to distributors and healthcare facilities, with approximately 2,378 Arthrex iBalance tibial trays withdrawn from the market.
Over one million patients undergo knee replacement surgery each year in the United States, with many of them receiving the iBalance TKA knee replacement system.
However, there has been recent concern regarding allegedly defective knee replacement implants being linked to serious health problems including nerve damage, potentially fatal infections, and even deep vein thrombosis.
Three major knee replacement implant manufacturers have recently issued recalls, with DePuy and Exactech performing the same action as Arthrex. Even though the Arthrex tibial tray recall prevents further injury occurrences, there are still numerous patients with this potentially defective knee implant.
Patients who may be impacted by the Arthrex tibial tray recall should be vigilant for any signs of device failure including:
- Severe Pain
- Inflammation
- Infection
- Bone Damage
- Muscle Damage
- Knee Component does not Bond to Bone
- Tibial Loosening
- Disassociation of the Implant Component
- Change in Component Position
- Patello Femoral Tracking-Lateral Release
Patients who suffer these complications often are forced to undergo revision surgery to resolve them, which is considered riskier than the initial implant procedure.
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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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