Important Safety Information

Important Safety Information

iBalance® UKA System

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Indications

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The iBalance UKA system is used to replace part of the knee to treat moderately disabling osteoarthritis joint disease caused by painful osteoarthritis or post-traumatic arthritis, improve knee alignment, correct a previous procedure, or as an alternative for patients with arthritis in one part of the knee. These components are single-use and secured in place with bone cement.

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Contraindications

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This system should not be used if you have poor bone quality; an active infection or limited blood supply; previous infections that could slow healing; significant knee joint deformity and/or repeated partial dislocation; inflammatory arthritis conditions, particularly rheumatoid arthritis; or a knee that is angled inward or outward by more than 15° and cannot be realigned by gentle manual correction. This system may not be suitable for patients with immature bones or those who cannot restrict activities or follow directions during the healing period. Excess body weight can place added stress on the knee, which may increase the risk of implant failure. Insufficient ligament support or soft‑tissue stability may compromise the secure positioning of the implant. Your doctor will consider your sensitivity to these materials before implantation. This system should not be used for any surgeries other than those indicated.

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Adverse Effects

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Possible side effects include infections; allergic reactions to component materials; reactions to implanted materials; bone fractures during or after the procedure; implant instability, shifting, or failure to remain securely fixed; deterioration or damage to the joint surfaces or surrounding soft tissue that supports the joint; development of calcified or bony tissue near the joint, potentially affecting mobility; and restricted mobility due to suboptimal implant selection or alignment.Small particles generated from implant wear, along with mild tissue discoloration from metal components, have been observed in other devices made from similar materials. Certain types of wear particles have been linked to bone loss and implant loosening. Additional risks of knee surgery may include joint locking, nerve or blood vessel injury, implant dislocation, bending of the implant components, differences in leg length, and other less common complications. Serious complications are possible with any total joint replacement procedure. These may include problems affecting the urinary or digestive systems; blood‑vessel–related issues such as blood clots; lung complications such as emboli; heart attack; or, in rare cases, death. Particles from metal and polyethylene components may be released during normal use over time. These particles can accumulate in the joint or travel to other areas of the body through natural biological processes. Potential long-term effects may include cancer, lymph node changes, buildup in other tissues or organs, and other systemic conditions.

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Warnings

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  • This system can only be sold by or on the order of a physician.
  • It should be used by trained medical professionals.
  • The implant contains nickel and may cause an adverse reaction for those with nickel sensitivities. Prior to surgery, you will be advised of the materials used in the device, and any suspected allergy will be evaluated and excluded before implantation.
  • The device should not be reused or resterilized.
  • Polished bearing surfaces must be protected from damage, as any scratches or alterations can accelerate component wear. Any implant component that has been damaged or modified should not be used, as it may fail under load.
  • Components should not be used with those of another manufacturer because alignment and size compatibility between components cannot be guaranteed.
  • Effective outcomes require appropriate preoperative preparation, knowledge of proper surgical methods, and accurate selection and positioning of the implant. The correct Arthrex delivery system must be used for implantation.
  • The fixation provided by the implant must be protected after surgery and until healing is fully achieved. Follow the prescribed postoperative regimen carefully to prevent placing undue stress on the device.
  • Device removal should be considered only after evaluating the risks of a second surgery. Proper postoperative management is essential after the device is removed.
  • This device is intended for single use only. Reuse may compromise device performance and cause harm.
  • The product’s functional lifespan varies among patients and depends on cumulative weight-bearing demands and lifestyle factors.
  • Follow your doctor’s postoperative instructions carefully to avoid stressing the device and components.
  • Report serious incidents to Arthrex, Inc., or its authorized representative, as well as to the appropriate health authority.

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If you have any questions or concerns, please discuss them with your health care provider.

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This is not medical advice and Arthrex recommends that surgeons be trained in the use of a particular product before using it in surgery. A surgeon must always rely on their own professional judgment when deciding whether to use a particular product when treating a particular patient. A surgeon must always refer to the package insert, product label, and/or directions for use before using any Arthrex product. Postoperative management is patient-specific and dependent on the treating professional's assessment. Individual results will vary and not all patients will experience the same postoperative activity level or outcomes. Products may not be available in all markets because product availability is subject to the regulatory or medical practices in individual markets. Please contact Arthrex if you have questions about availability of products in your area. Patient images, videos, and/or testimonials are used with written authorization from the patient.