Patient Risk Information
Biomet Elbow and Shoulder Joint Replacement Prostheses

DESCRIPTION

Biomet manufactures a variety of elbow and shoulder joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.

Elbow joint replacement components include: humeral and ulnar components, and a hinge component. Components are available in a variety of surface finishes including: Bond Coat (a thin layer of titanium plasma spray) and Interlok. Small diameter cement plugs are available as specialty components.

Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components. Components are available in a variety of designs and size ranges for both primary and revision applications. Specialty components include glenoid screws, centering sleeves and bipolar heads.

INDICATIONS

You may be a candidate for surgery if your surgeon determines you have any of the following:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods.
6. Oncology applications.

Patient selection factors to be considered include:1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity.

CONTRAINDICATIONS

You are not a candidate for surgery if your surgeon determines you have any of the following: infection, sepsis, and osteomyelitis. You may not be a candidate for surgery if your surgeon determines that any of the following apply to you: 1) uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

WARNINGS

Improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure. Inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear. Improper preoperative or intraoperative implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture and/or excessive wear.

Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients. While these devices are generally successful in attaining these goals they cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue.

Accepted practices in postoperative care are important. Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure. The patient is to be advised of the limitations of the reconstruction and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred. Excessive activity, trauma and excessive weight have been implicated with premature failure of the implant by loosening, fracture, and/or wear. Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone, making successful revision surgery more difficult. The patient is to be made aware and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician including follow-up visits.

PRECAUTIONS

1. Patient must avoid placing excessive loads on the implant.
2. Patient must avoid lifting more than 5lbs with the operated arm after surgery.
3. Patient must avoid putting full body weight on the operated arm when rising from a seated position.
4. Patient must avoid sudden or strenuous pulling activities after surgery, as these can produce excessive stress on the operated arm.

POSSIBLE ADVERSE EFFECTS

1. Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may result in loosening of the implant.
2. Early or late postoperative infection, and allergic reaction.
3. Intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device.
4. Infection is a rather common problem in elbow procedures.
5. Injury to the ulnar nerve impairment is a major concern in elbow procedures.
6. Loosening, migration, and/or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity.
7. Periarticular calcification or ossification, with or without impediment of joint mobility.
8. Inadequate range of motion due to improper selection or positioning of components.
9. Undesirable shortening or lengthening of limb.
10. Dislocation and subluxation due to inadequate fixation, improper positioning, trauma, excessive range of motion, and/or excessive activity. Muscle and fibrous tissue laxity can also contribute to these conditions.
11. Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.
12. Fretting and crevice corrosion can occur at interfaces between components.
13. Wear and/or deformation of articulating surfaces.
14. Accelerated wear of glenoid articular cartilage.
15. Intraoperative or postoperative bone fracture and/or postoperative pain.
16. Axle or bearing components may disassociate causing the elbow to disarticulate.