Ortholoc 2 LapiFuse Triplanar Correction System

Intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include arthrodesis of the first metatarsocuneiform joint (Lapidus fusion).

GENERAL SURGICAL CONTRAINDICATIONS
Infection
Physiologically or psychologically inadequate patient
Inadequate skin, bone, or neurovascular status
Irreparable tendon system
Possibility for conservative treatment
Growing patients with open epiphyses
Patients with high levels of activity
 
There are no contraindications specific to the products.

Following the instructions for use provided in product literature can minimize the potential for complications or adverse reactions with any implant. It is the responsibility of each surgeon using implants to consider the clinical and medical status of each patient and to be knowledgeable about all aspects of implant procedure and the potential complications that may occur. The benefits derived from implant surgery may not meet the patient's expectations or may deteriorate with time, necessitating revision surgery to replace the implant or to carry out alternative procedures. Revision surgeries with implants are common. The patient's mental status must also be considered. Willingness and/or ability to follow post-operative instructions may also impact the surgical outcome. Surgeons must balance many considerations to achieve the best result in individual patients. IF EXCESSIVE LOADING CANNOT BE PREVENTED, AN IMPLANT SHOULD NOT BE USED.
 
The main goal of surgery with this implant is to establish bony fusion. Abnormal or excessive forces could lead to delayed union, non-union, or failure of the implant. Abnormal force loading and subsequent wear may be caused by:

• Uncorrected instability
• Improperly sized implant
• Inadequate soft tissue support
• Implant malposition
• Excessive motion
• Uncorrected or recurrent deformity
• Patient misuse or overactivity

Proper fixation at the time of surgery is critical to the success of the procedure. Bone stock must be adequate to support the device. Some preventative measures to consider to minimize the potential for complications:

• Follow guidelines for indications and contraindications provided above
• Identify prior pathology • Stabilize collapsed deformities
• Bone graft pre-existing cysts
• Use a properly sized implant
• Avoid K-wires and sutures through the implant
• Avoid open wedge osteotomies of the lower tibia which could be a higher load bearing environment.

Avoid flawing implant surfaces to minimize the potential for early fatigue failure. If complications develop, possible corrective procedures include:
• Implant removal
• Synovectomy
• Bone grafting of cysts
• Replacement of the implant
• Removal of the implant with fusion of the joint
 
Clinical results depend on surgeon and technique, preoperative and postoperative care, the implant, patient pathology and daily activity. It is important that surgeons obtain appropriate informed consent and discuss the potential for complications with each patient prior to surgery. This may include a review of alternative, non-implant procedures such as soft tissue reconstruction or arthrodesis.