Neuflex MCP/PIP Finger Joint Implant Essential Product Information

Important:

This essential product information does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information.

Indications:

The NeuFlex MCP and PIP Finger Joint Implants are indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative, or traumatic arthritis.

Contraindications:

The NeuFlex MCP and PIP Finger Joint Implants are contraindicated in the following:

1. Active local or systemic infection.
2. Destruction of the metacarpal or phalanx or poor bone quality which prevents adequate fixation of the implant.
3. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected finger.
4. Growing patients with open epiphyses.
5. Patients with high activity levels.
6. Patients unwilling or unable to comply with the physician's instructions.

Warnings and Precautions:

The following conditions, singularly or concurrently, tend to place excessive loads on a finger joint implant and thereby, place the patient at higher risk for failure of finger joint replacement:

1. Excessive activity of the affected joint
2. Uncorrected or recurrent deformity
3. Incorrect sizing of the implant
4. Inadequate soft tissue or bony support
5. Implant malposition

If excessive loading of the affected finger cannot be prevented, a finger joint implant should not be used. Benefits of finger joint replacement may not meet patient’s expectations or may deteriorate over time. Pain, swelling, instability and/or deformity may persist or return after finger joint replacement.

Adverse Events:

The following are generally the most frequent adverse events or complications encountered in finger joint replacement:

1. Failure of the implant due to fatigue, wear or over-loading
2. Early or late infection
3. Wear particles caused by the movement and wear of a silicone rubber implant may cause or exacerbate synovitis or bone cyst formation
4. There have been reports in the literature, which suggest that some individuals may have an immunological reaction to silicone implants, resulting in connective tissue and/or autoimmune disease. If these conditions are suspected, removal of the silicone device should be considered.

Last Updated: 09/09/2008