Arthrex iBalance Total Knee Arthroplasty

A knee replacement is supposed to last many years — often a decade or more. But many patients implanted with the recalled Arthrex iBalance are required to undergo a risky revision surgery to correct tibial loosening just a couple of years after their initial procedure.
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Purpose of Arthrex iBalance TKA

The Arthrex iBalance TKA is a knee replacement system. It is approved for total knee replacement due to the following conditions: (1)

  • Knee cartilage degeneration caused by osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis.
  • Revision of a previous knee replacement.
  • Certain knee deformities.

Knee replacement surgery, also known as total knee arthroplasty (TKA), is a common orthopedic surgeries. During the procedure, a surgeon replaces a damaged or diseased knee joint with artificial parts. The Arthrex iBalance is one of several different types of knee replacement systems on the market.

Defective Design

The Arthrex iBalance TKA contains multiple components. One of these components is a tibial tray (also called a baseplate). The tibial tray replaces the top of the tibia, or shinbone. It is made of metal and attaches to the bone with cement. (2)

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The recalled iBalance tibial tray was manufactured with a smooth outer surface that was different from what was previously approved, which had a textured outer surface. This change in surface texture appears to correspond to a pattern of failed devices due to loosened tibial trays. (3)

Multiple reports from the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database describe patients requiring revision surgery due to tibial loosening. (4) (5) (6) These reports and several others suggest poor bonding between the metal implant and knee.

Voluntary Recall

In December of 2015 and March of 2016, Arthrex initiated recalls of the Arthrex iBalance TKA Tibial Tray. The reason for the recalls was the “smooth texture to the outer surface of the metal” that differed from the previously approved “textured outer surface.” (7)

On February 5, 2016, Arthrex sent “Urgent Medical Device Voluntary Recall Letters” to distributors, surgeons, and medical centers instructing them to discontinue using and return the devices that had not yet been implanted. Nearly 2,400 devices had been distributed in the U.S. by the time of the recalls. (8)

In March of 2016, the FDA classified the recalls as Class II. They determined the cause of the recalls to be “Nonconforming material/component.” (9)

Doctor checking knee

Symptoms That Your Arthrex iBalance Knee Failed

A knee implant is supposed to last for many years. But a loose tibial baseplate can cause an implant to fail soon after implantation. A failed implant can be excruciatingly painful and even debilitating.

Signs that your Arthrex iBalance knee has failed may include:

  • Swelling.
  • Pain.
  • Instability.
  • Loss of range of motion.
  • Inability to walk.

A failed implant is a serious matter. If you have had a knee implant and are experiencing these symptoms, we encourage you to see your doctor for an examination.

Knee Implant Revision Surgery

The MAUDE database contains multiple reports of patients with Arthrex iBalance TKA implants who had to undergo revision surgery due to tibial tray loosening. (10) (11) (12)

Even more concerning is that “the success rate for revision surgery is usually lower than that for the original surgery because the bone is weaker.” (13)

If a defective product put you in unnecessary risk or damaged your health, the manufacturer should be held accountable. Arthrex iBalance patients forced to undergo revision surgery due to tibial tray loosening may be eligible to file a lawsuit.

Arthrex iBalance TKA Lawsuits

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Weitz & Luxenberg is currently accepting cases from patients who were implanted with an Arthrex iBalance TKA prior to the recall in December 2015 and subsequently had a revision, or have been told they require a revision, due to tibial baseplate loosening. We believe that if an implant design necessitates you have a revision surgery after just a couple of years, you were put at unnecessary risk and the manufacturer should be held responsible.

W&L’s attorneys in our Drug and Medical Devices Litigation Unit have years of experience and specialized training in handling complex medical device lawsuits. Under the helm of the unit’s co-chair, Ellen Relkin, our attorneys have a long track record of successfully representing osteoarthritis and joint patients, among many others, harmed by medical devices and pharmaceuticals:

We are also currently helping patients experiencing similar issues of component loosening in other knee implants, including the tibial baseplate of the DePuy Synthes Attune Knee and the femoral component of the Smith & Nephew Journey BCS Knee replacement system.

The attorneys at our law firm believe that when medical device companies bring defective products to market, they are gambling with the health and safety of patients. These companies should take responsibility for the harm they caused.

If you were hurt by a medical device that didn’t function properly, you should be fully compensated for the pain, suffering, medical costs, and other personal and financial injuries you suffered.

  1. Food and Drug Administration (2008, October 17).Summary of Safety and Effectiveness. ACCIN Total Knee System. Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf8/K081127.pdf
  2. Arthrex. (2016). iBalance TKA. The Ideal Balance of Simplicity and Performance in Total Knee Arthroplasty. Retrieved from https://d1psc3qesfsa61.cloudfront.net/pdfs/N9nRkDCZF0GDIQFNDBC4BQ/N9nRkDCZF0GDIQFNDBC4BQ.pdf?Expires=1561560224&Signature=Qd50LOcKHOc6v8MI-%7Evw-hFU27pOgMp6vEICaGY15NnhCb2uVI4XbchX-dZML7fqfnQZGwkPzoclpHwtYzXFhPPa0DrvzCfS6NAROrDZaLlRP87kGPcS3-CsY4aBdxnE%7EsNo1b8YRypIugKO%7EayxUAXvo5G3xQuBfWKmfQei4QT8o8byc9idGgp5lAJ0Wf1Y%7E-nrR6H6sGDiePHP9sGGj5RMTY30kQrcb9AU5R1tBa-2sAE%7ExlT--e1pigCcVVfxCSfSeFv8tUah2SJ8ie6KdTOxNZvW4zpI73zztoqMnyWPbvXSVA8WTG3iNtmmWzWANKAnG83qcxicUPz82hKlJA__&Key-Pair-Id=APKAJMGJRW6JX5OBM5LA
  3. U.S. Food & Drug Administration. (2016, March 19). Class 2 Device Recall Arthrex IBalance TKA Tibial Tray. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143925
  4. U.S. Food & Drug Administration. (2017, March 13). MAUDE Adverse Event Report: Arthrex, Inc. IBalance TKA Tibial Tray Size 4 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal. Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6476676&pc=JWH
  5. U.S. Food & Drug Administration. (2017, February 20). MAUDE Adverse Event Report: Arthrex, Inc. IBalance TKA Tibial Tray Size 8 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6401992&pc=JWH
  6. U.S. Food & Drug Administration. (2017, January 30). MAUDE Adverse Event Report: Arthrex, Inc. IBalance TKA Tibial Tray Size 8 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6360421&pc=JWH
  7. U.S. Food & Drug Administration. (2016, March 19). Class 2 Device Recall Arthrex IBalance TKA Tibial Tray. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143925
  8. Ibid.
  9. Ibid.
  10. U.S. Food & Drug Administration. (2017, March 13). MAUDE Adverse Event Report: Arthrex, Inc. IBalance TKA Tibial Tray Size 4 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal. Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6476676&pc=JWH
  11. U.S. Food & Drug Administration. (2017, February 20). MAUDE Adverse Event Report: Arthrex, Inc. IBalance TKA Tibial Tray Size 8 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6401992&pc=JWH
  12. U.S. Food & Drug Administration. (2017, January 30). MAUDE Adverse Event Report: Arthrex, Inc. IBalance TKA Tibial Tray Size 8 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6360421&pc=JWH
  13. Cedars-Sinai. (n.d.). Revision Hip Surgery. Retrieved from https://www.cedars-sinai.org/health-library/diseases-and-conditions/r/revision-hip-surgery.html

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