ABGII Modular Femoral Stem and Modular Neck - update

The TGA previously published information for health professionals and consumers regarding the ABGII Modular system on its website on 20 July 2012.

Health professionals and consumers are advised that sponsor Stryker Australia Pty Ltd, in consultation with the TGA, has issued updated information regarding patient follow-up for the ABGII Modular Femoral Stem and Modular Neck hip replacement system.

The ABGII Modular system was recalled and cancelled from the Australian Register of Therapeutic Goods (ARTG) in July 2012 because of potential wear and corrosion between the metal surfaces of the femoral stem and the neck component of the implant. This wear is due to microscopic movement between the metal surfaces. This can lead to patients experiencing inflammation and pain, as well as other serious reactions.

On 10 July 2012, Stryker Australia Pty Ltd issued a Hazard Alert asking orthopaedic surgeons who had implanted the ABGII Modular system to contact patients to discuss appropriate clinical action.

Since then, there have been reports of:

• asymptomatic patients who have developed soft tissue injury identified on imaging
• a patient who had developed symptoms a short time after review and who was found to have both raised chromium and cobalt ion levels and soft tissue injury identified on imaging.

The TGA is monitoring these and other modular hip implant components closely.

Information for consumers

If you are experiencing hip or thigh pain, or are concerned about your hip replacement, contact your implanting surgeon to arrange a review appointment.

If you are not experiencing hip or thigh pain and are not concerned about your hip replacement, then continue with the follow-up schedule agreed between you and your surgeon.

Information for orthopaedic surgeons

Stryker Australia Pty Ltd has written to orthopaedic surgeons who have used the ABGII Modular system to advise them of updated patient follow-up information.

When following up with patients with an ABGII Modular system, orthopaedic surgeons are advised to:

• consider performing a clinical examination, including regular testing for cobalt and chromium in the blood and cross-sectional imaging of the soft tissue, even if the patient is not experiencing pain and/or swelling
• consider repeat follow-up examinations, even if the initial findings are normal
• continue to evaluate patients for aseptic loosening and periprosthetic sepsis
• if an adverse response to metal wear debris is detected, consider revising the femoral component to a device without a modular neck.

Stryker Australia Pty Ltd has also advised that the potential hazards identified in the 10 July 2012 Hazard Alert are unchanged.

Information for all health professionals

Patients with any hip replacement should be followed up by the implanting orthopaedic surgeon if possible, particularly if the patient complains of pain and other symptoms associated with their hip implant and surgery.

Additional informationedical devices

Fretting and corrosion can result in metal debris in and around the hip joint. If this occurs, patients may experience inflammation, adverse local tissue reactions (ALTRs), hypersensitivity/allergic reactions and osteolysis (bone loss). However, in some cases, they may not experience any symptoms.

The TGA has been advised that 258 ABGII Modular Femoral Stem and Modular Neck systems have been implanted in Australia since 2007 and none have been implanted since February 2012.

The worldwide rate of complaints received by the manufacturer related to ALTR leading to revision, in relation to the total number of implanted ABGII Modular components, is now just over 0.5%.

ABGII femoral implants with fixed (non-modular) necks were not recalled.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.