Table of contents
- Latest Arthrex Knee Lawsuit Updates
- December 14, 2016: FDA Terminates the Recall
- March 19, 2016: FDA Records a Class 2 Recall
- February 5, 2016: Arthrex Sends Recall Letters
- December 17, 2015: Arthrex Starts the Recall
- What Is the Arthrex iBalance Knee System?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- Can I File an Arthrex Knee Lawsuit for a Bad Knee Replacement?
- How Do I Know If My Knee Implant Is an Arthrex Device?
- Which States Received the Recalled Arthrex Tibial Trays?
- What Does the Research Say About Follow-Up After a Recalled Knee Implant?
- Who Do I Contact About a Recalled Arthrex Tibial Tray?
The Arthrex iBalance TKA Tibial Tray, part of a knee implant system made by Arthrex, Inc. of Naples, Florida, was the subject of an FDA Class 2 recall. It covered sizes 2 through 8 of a cemented tray.
Arthrex started the recall in December 2015, and the FDA ended it in December 2016. Devices were reported to have a smooth outer metal surface instead of the earlier textured surface.
No MDL, class action or settlement has been reported, and no court has made a finding about these knee implants. Anyone with a painful or failed knee implant may want to confirm which device they received.
Latest Arthrex Knee Lawsuit Updates
December 14, 2016: FDA Terminates the Recall
The FDA terminated the recall of the Arthrex iBalance TKA Tibial Tray on December 14, 2016, according to the FDA recall record [1].
March 19, 2016: FDA Records a Class 2 Recall
The FDA recorded the tray recall as Class 2 on March 19, 2016. The recall number is Z-1195-2016. The same FDA record lists 2,378 units in commerce.
February 5, 2016: Arthrex Sends Recall Letters
Arthrex sent Urgent Medical Device Voluntary Recall letters to distributors and to surgeons or medical facilities on February 5, 2016. Users were to stop using the devices and return those not implanted.
December 17, 2015: Arthrex Starts the Recall
Arthrex initiated the recall of its iBalance TKA Tibial Tray, sizes 2 through 8, on December 17, 2015. The tray is part of the iBalance knee system.
Earlier versions of the tray had a textured outer surface. The FDA record lists the surface difference as the manufacturer’s reason for the recall.
What Is the Arthrex iBalance Knee System?
According to the FDA, the Arthrex iBalance TKA Tibial Tray is a knee prosthesis part. The FDA classes it as a semi-constrained, cemented knee prosthesis under product code JWH. It is intended for implantation with bone cement.
The FDA recall record lists 510(k) K081127 for this device. That clearance record has a decision date of October 17, 2008, and carries the name Accin Total Knee System from applicant Accelerated Innovation, LLC [2].
Who May Be Affected?
People who had a total knee replacement with an Arthrex iBalance knee implant may be affected. The recall covered a cemented iBalance TKA Tibial Tray in sizes 2 through 8, and unimplanted units were to be returned.
A recall alone does not prove a claim, and only an individual legal review can say whether you qualify for any claim.
Reported Injuries or Damages
The FDA lists no injury reports for the Arthrex iBalance tray. Any injury claims over iBalance knees would be allegations, not findings.
For a different maker, a Hospital for Special Surgery taskforce wrote that recalled Exactech knee polyethylene wear “could lead to bone loss, aseptic loosening, and need for revision surgery” [3].
Recall and Regulatory Background
The FDA lists the cause of the Arthrex recall as a nonconforming material or component. Its Class 2 recall record covers the iBalance TKA Tibial Tray only. Each knee implant case depends on the patient’s own records.
Evidence to Preserve
Keep every record that shows which knee implant you received and how it has affected you:
- Implant card or sticker from your surgery
- Operative report naming the maker and catalog number
- Lot or batch number and unique device identifier
- Hospital and surgeon records
- X-rays and scans
- Records of pain, loosening and revision surgery
- Bills and out-of-pocket costs
- Recall letters you received
- Photographs of any removed device
- A diary of symptoms and lost work
Filing Deadlines
Filing deadlines come from state law and depend on your home state and on when you learned of the injury and its cause.
A claim filed too late can be barred, however strong the facts of your case may be. Speak with a lawyer promptly. A lawyer can tell you which state deadline applies to you and when it began to run.
Frequently Asked Questions
Can I File an Arthrex Knee Lawsuit for a Bad Knee Replacement?
Whether you can file an Arthrex knee lawsuit over a bad knee replacement depends on your implant, your injury and your medical records. Only the facts of your own case can answer that. A failed implant of a different maker may not be covered by the recall.
How Do I Know If My Knee Implant Is an Arthrex Device?
You can tell if your knee implant is an Arthrex device by matching catalog numbers AR-503-TTTC through AR-503-TTTJ. The FDA record also lists unique device identifiers from 00888867106703 for size 2 to 00888867106765 for size 8.
Which States Received the Recalled Arthrex Tibial Trays?
The recalled Arthrex tibial trays went to these states and the District of Columbia, according to the FDA record: AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, WA and WI.
What Does the Research Say About Follow-Up After a Recalled Knee Implant?
Research on follow-up after a recalled knee implant comes from Exactech knees, not Arthrex. The taskforce advised follow-up every 2 to 3 years for patients with no symptoms and more often for mild symptoms.
Who Do I Contact About a Recalled Arthrex Tibial Tray?
You can contact Arthrex customer service about a recalled Arthrex tibial tray at 866-267-9138. The FDA recall record also lists the email address Complaints@Arthrex.com for returns of devices that were not implanted.