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Patient Risk Information1,2

As with most surgery, comes risk. To help minimize risk, it is important to follow the post-operative care instructions provided by your surgeon and attend regular follow-up appointments. See below for the risks associated with the Zimmer Biomet RibFix products.

The RibFix Blu system is indicated for use in the stabilization and fixation of fractures in the chest wall, including sternal reconstructive surgical procedures, trauma, or planned osteotomies. While uncommon, complications can occur during and after surgery.  Complications include, but are not limited to:

  • Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device.
  • Nonunion or delayed union which may lead to breakage of the implant.
  • Migration, bending, fracture or loosening of the implant.
  • Metal sensitivity; or allergic reaction to a foreign body.
  • Decrease in bone density due to stress shielding.
  • Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.
  • Increased fibrous tissue response around the fracture site and/or the implant.
  • Necrosis of bone.
  • Inadequate healing.
  • Selection of screws which are longer than the depth of the bone may cause possible impingement on structures internal to chest wall including vessels, pleura and other structures.

 

Patients with any of the following conditions are not candidate for treatment with RibFix Blu:

  • Spanning a midline sternotomy.
  • Active infection.
  • Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
  • Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

 

The RibFix Advantage System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone. While uncommon, complications can occur during and after surgery.  Complications include, but are not limited to:

  • Nonunion or delayed union which can lead to breakage of the implant.
  • Metal sensitivity, or allergic reaction to a foreign body.
  • Limb shortening due to compression of the fracture or bone resorption.
  • Decrease in bone density.
  • Pain, discomfort, or abnormal sensations due to the presence of the device.
  • Nerve damage due to surgical trauma.
  • Necrosis of bone.
  • Vascular changes.

 

Patients with any of the following conditions are not candidate for treatment with RibFix Advantage:

  • Use in patients with latent or active infection, sepsis, and/or device material sensitivity.
  • Use in patients who are unwilling or incapable of following postoperative care instructions.
  • This device is not intended for locking post attachment or fixation to the clavicle or spine.
  1. RibFix Blu IFU. 01-50-1605.
  2. RibFix Advantage IFU. 01-50-1700.
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To find a doctor near you, click the ‘find-a-doc’ link. For printed information on joint replacement, call 1-800-447-5633.
Talk to your surgeon about whether joint replacement or another treatment is right for you and the risks of the procedure, including the risk of implant wear, loosening or failure, and pain, swelling and infection. Zimmer Biomet does not practice medicine; only a surgeon can answer your questions regarding your individual symptoms, diagnosis and treatment.