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Biomet
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Shoulder Pain / Shoulder Replacement Products
Comprehensive® Reverse Shoulder Replacement

Patient Risk Information


 

Rotator Cuff Tear
If you are a potential candidate for reverse shoulder replacement, you may be suffering from pain as a result of a previous rotator cuff tear. A cuff-tear causes your shoulder joint to lose much of its natural support, leading to increased instability. Often, this results in the normal shoulder becoming destabilized, and moving out of socket completely. Over time, this instability leads to bone-on-bone contact, moderate to severe pain, and extremely limited mobility.

Comprehensive® Reverse Shoulder Replacement
The word 'replacement' makes one think that surgeons remove the entire shoulder. In truth, surgeons only replace the damaged bone and cartilage at the ends of the bones in the joint. Reverse shoulder replacement has revolutionized the treatment of massive rotator cuff tears. The unique procedure reverses the anatomy of the shoulder. It is designed so that the ball is attached to the shoulder blade (scapula) and the socket is placed on top of the upper-arm bone (humerus). By reversing the normal anatomy, the deltoid muscle, one of the stronger shoulder muscles and the only abducting muscle remaining in the shoulder is given control to raise the arm.

The Comprehensive® Reverse Shoulder implant from Biomet offers surgeons many options for restoring function and reducing pain. The shoulder system is the next generation reverse shoulder prosthesis, offering unmatched surgical flexibility for orthopedic surgeons. Most candidates for reverse shoulder replacement are in extreme pain, have almost no shoulder mobility and have tried various treatment options, often times including primary shoulder replacement. Reverse shoulder replacement is intended to alleviate pain and improve mobility to the point of being able to perform activities of daily living (ADLs).

The goals of reverse shoulder replacement include:

  • Pain relief
  • Improved function

After Surgery
After surgery, patients typically spend one to two nights in the hospital. The arm may be in a sling for a period of time and the length of recovery time will vary with each person. Physical therapy after surgery is individualized to each patient and is typically guided by the orthopedic surgeon. While the goals of reverse shoulder replacement are to reduce pain and restore motion, it is important to strictly follow your surgeon's advice regarding activity after surgery.

Even though you may have reduced pain and improved function, always remember to limit your activities to those cleared by your orthopedic surgeon. If you have specific questions regarding activities after surgery, please speak with your surgeon.

Indications for Use of the Device
Biomet® Comprehensive® Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Possible Adverse Effects and Risks
Some possible adverse effects of surgery include material sensitivity reactions, early or late postoperative infection and allergic reaction, loosening, dislocation, fracture, or wear, any of which can require additional surgery. Please see the "patient risk information" for complete warnings and potential adverse effects.

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. The use of a reverse shoulder prosthesis in patients with a deficient rotator cuff could increase the risk of component loosening due to non-anatomic loading conditions. Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure.

Biomet is a manufacturer of orthopedic implants and does not practice medicine. Only an orthopedic surgeon can determine what treatment is appropriate. Individual results of total joint replacement may vary. The life of any implant will depend on your weight, age, activity level, and other factors. For more information on risks, warnings, and possible adverse effects, see the Patient Risk Information section found within Biomet.com. Always ask your doctor if you have any questions regarding your particular condition or treatment options.


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