Risks
All surgeries, whether inpatient or outpatient procedure, have risks. That is why your surgeon will have lab tests and a physical exam done before your surgery.
The risks and complications associated with the CONSERVE® PLUS Total Resurfacing Hip System are expected to be similar to those of other resurfacing and/or hip replacements. The risks and complications include:
- Excessive bleeding
- Damage of blood vessels may occur due to surgery
- Delayed wound healing
- Sudden drop in blood pressure during surgery due to the use of bone cement or anesthesia
- Temporary or permanent nerve damage
- Allergic reaction due to anesthesia, medication, or device material
- Allergic reaction to the implant's materials. As the parts rub against each other, metal ions are released into the body, which may cause an allergy. There are no known medical consequences of these ions at this time, however, studies are ongoing.
- Infection, which can lead to removal of the device
- The femoral neck may break
- Device loosening from the surrounding bone
- Increase in hip pain and/or reduced function
- Hardening of the tissue (calcifications) or bony points around the devices
- Device related noise such as, clicking, popping, squeaking or grinding
- Ball and socket may separate (hip dislocation)
- Overuse of the device from too much weight or activity may cause the device to fail prematurely
- Change in the length of the treated leg (limb length discrepancy)
- Premature wear or breakage of the implant
- Bone breakage due to osteoporosis or accidents (trauma)
- Damage to the bones and tissue (tissue necrosis, pseudotumor) near the hip joint, including loss of the surrounding bone (osteolysis) or staining of the hip joint fluid (metalosis) due to wearing of the metal parts over time
- Pseudotumor
- Chronic inflammatory response due to metal sensitivity (Aseptic Lymphocyte Dominant Vasculitis Associated Lesion - ALVAL)
These potential adverse events may require additional medical and/or surgical procedures and should be discussed with your surgeon. Rarely these complications can lead to death.
For additional information on the CONSERVE® PLUS Total Resurfacing Hip System, please review the patient information brochure.
