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U.S. Department of Health and Human Services

Medical Devices

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Keramos™ Ceramic/Ceramic Total Hip System - D980003

Photo of Keramos™ Ceramic/Ceramic Total Hip System - D980003This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.


Product Name: Keramos™ Ceramic/Ceramic Total Hip System
Manufacturer: Encore Medical, L.P.
Address: Encore Medical, L.P., 9800 Metric Boulevard, Austin, Texas 78758
Approval Date: November 26, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/d980003a.pdf

What is it? The Encore Keramos™ Ceramic/Ceramic Total Hip System is an alumina ceramic artificial hip replacement system, surgically implanted to completely replace a diseased hip joint.

How does it work? The system has four parts that work together to allow the hip joint to move:

  • A metal hip stem, that a doctor places into a hole drilled in the end of the thigh bone,
  • A ceramic, ball-shaped part (femoral head) that fastens to the metal hip stem,
  • A ceramic, socket-shaped part (acetabulum) that the ball-shaped part fits in, and
  • A metal shell that fastens the ceramic socket-shaped part to the hip bone.

The ceramic ball slides around in the ceramic socket, which allows this artificial hip joint to move.

When is it used? The Keramos™ Ceramic/Ceramic Total Hip System is for patients who need a total hip replacement because of painful inflammatory or non-inflammatory arthritis. Examples of inflammatory arthritis are:

  • pain,
  • swelling, and
  • gradual degeneration of tissues surrounding the joint.

Examples of non-inflammatory arthritis are:

  • wearing out of the joint due to age,
  • lack of blood flow to the bone, or
  • joint damage due to injury.

What will it accomplish? The Keramos™ Ceramic/Ceramic Total Hip System relieves pain and allows for increased function in the hip.

When should it not be used? The Keramos™ Ceramic/Ceramic Total Hip System should not be used in patients who have:

  • an infection in or near the hip joint,
  • bones that are still growing,
  • neurological disorders which might prevent the patient from following instructions during postoperative care,
  • diseased or infected bones that cannot support or fasten to the prosthesis, or
  • bones damaged by an earlier implant that cannot support or fasten to the prosthesis.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=d980003

Other:

  • Comprehensive list of things to help after hip surgery:
http://orthoinfo.aaos.org/fact/thr_report.cfm?Thread_ID=274&topcategory=Hip
  • Diet, home safety tips to avoid hip injury:
http://orthoinfo.aaos.org/brochure/thr_report.cfm?Thread_ID=25&topcategory=Hip
  • Description of bone density scan to diagnose osteoporosis:
http://www.cc.nih.gov/ccc/patient_education/procdiag/bonedensity.pdf